Name: Fda Devices
Author: pipeworx-io

Fda Devices MCP

FDA medical-device regulatory intelligence from keyless openFDA datasets.

not scanned Remote · Streamable HTTP No auth needed 11 tools v0.1.7

No reviews yet by pipeworx-ioGitHub The publisher’s own endpoint — this marketplace is not in the path

tools declared

—

trust score

remote

at its publisher

—

calls last 7d

What it does

FDA medical-device regulatory intelligence from keyless openFDA datasets.

Quickstart

# 1 — add it to Claude Code
claude mcp add --scope user --transport http fda-devices-mcp https://gateway.pipeworx.io/fda-devices/mcp

# 2 — ask your agent for something these tools do
#   fda_device_510k_search, fda_device_510k_summary, fda_device_pma_search and 8 more

Fda Devices costs nothing on mcprush: there is no plan to choose here, no cap to set and nothing mcprush can bill you for.

Publishernot claimed

pipeworx-io1825 servers

29 categories

All 1825 servers

Collected from a public index. Nobody has claimed this account, so nothing here was written by its author — claim it if it is yours.

Tool surface

What the model actually sees. Descriptions are diffed on every release — see version history.

Only tools that write or reach the network

Search FDA 510(k) premarket notifications by device, applicant, product code, K number, review panel, clearance type, decision, applicant location, third-party review status, or device-category text (via indication). Covers IN VITRO DIAGNOSTIC (IVD) tests and diagnostic devices, not just implants/hardware -- includes cleared molecular, genomic and companion diagnostic tests. Clearance means FDA

Parameter	Type	Required	Notes
device	string	no	Device/trade name substring.
indication	array	no	One or more device-category phrases, OR'd together, matched against FDA's device classification name/definition (device/classification.json) to find matching product code(s), then 510(k)s under those
applicant	string	no	Applicant/company substring.
product_code	string	no	Exact three-letter FDA product code.
k_number	string	no	Exact K number, e.g. K241234.
from_date	string	no	Earliest decision date, YYYY-MM-DD.
to_date	string	no	Latest decision date, YYYY-MM-DD.
advisory_committee	string	no	FDA review panel name (exact), e.g. "Orthopedic" or "Microbiology".
clearance_type	string	no	Exact clearance type: Traditional, Special, or Abbreviated.
decision	string	no	Exact decision text, e.g. "Substantially Equivalent".
applicant_country	string	no	Applicant country, ISO 3166-1 alpha-2 code, e.g. "US" or "JP".
applicant_state	string	no	Applicant US state/territory code, e.g. "CA". Only populated for US applicants.
third_party_review	boolean	no	true to keep only 510(k)s reviewed under FDA's third-party review program; false to exclude them.
limit	number	no	Results (1-100, default 20).
skip	number	no	Row offset for paging past the 100-row limit cap (openFDA skip, max 25000), e.g. skip=100 with limit=100 returns rows 101-200.

Get the FDA 510(k) summary/statement document and FDA review (decision memo) for one clearance, by K number — the actual filing, not just the "a document exists" flag from fda_device_510k_search. Shows the predicate device claimed and the testing behind the equivalence finding. Older/paper-only clearances were never digitized; that returns summary_available:false with a reason, not an error.

Parameter	Type	Required	Notes
k_number	string	yes	Exact K number, e.g. K253470.

Search FDA Premarket Approval (PMA) decisions and supplements by trade/generic name, applicant, product code, PMA number, or CLINICAL INDICATION/condition text (via indication). Which diagnostic tests are FDA-approved: covers high-risk IN VITRO DIAGNOSTIC (IVD) tests approved via PMA, including companion diagnostics and molecular residual disease (MRD) / ctDNA monitoring tests (e.g. Signatera, G

Parameter	Type	Required	Notes
device	string	no	Trade or generic device name substring.
indication	array	no	One or more clinical indication / intended-use / condition phrases, OR'd together, matched as exact phrases against the FDA approval-order narrative text (ao_statement) -- NOT the device name. Use thi
applicant	string	no	Applicant/company substring.
product_code	string	no	Exact FDA product code.
pma_number	string	no	Exact PMA number, optionally including supplement suffix.
from_date	string	no	Earliest decision date, YYYY-MM-DD.
to_date	string	no	Latest decision date, YYYY-MM-DD.
limit	number	no	Results (1-100, default 20).

Search FDA medical-device recall records by firm, product, product code, K number, status, or date. A recall record describes a correction/removal action and does not by itself establish patient harm.

Parameter	Type	Required	Notes
query	string	no	Product or reason text.
firm	string	no	Recalling firm substring.
product_code	string	no	Exact FDA product code.
k_number	string	no	Exact related K number.
status	string	no	Recall status, e.g. Ongoing or Terminated.
from_date	string	no	Earliest posted date, YYYY-MM-DD.
limit	number	no	Results (1-100, default 20).

Search FDA MAUDE medical-device reports by manufacturer, brand/device, product code, event type, or PMA/510(k) number. MAUDE reports are unverified signals: they cannot establish causation, incidence, prevalence, or comparative safety.

Parameter	Type	Required	Notes
device	string	no	Brand or generic device name.
manufacturer	string	no	Manufacturer name.
product_code	string	no	Exact product code.
event_type	string	no	Death, Injury, Malfunction, or Other.
application_number	string	no	PMA or 510(k) number.
from_date	string	no	Earliest FDA receive date, YYYY-MM-DD.
limit	number	no	Results (1-50, default 10).

Aggregate MAUDE reports for a device query by event type, manufacturer, product code, or receive date. Counts reflect reporting and database artifacts—not event rates or causal risk—and must not be compared without exposure denominators.

Parameter	Type	Required	Notes
query	string	no	Optional raw openFDA MAUDE filter, e.g. 'date_received:[20250101+TO+20261231]'. Omit to rank across all reports.
count_field	string	yes	What to rank by. For "which DEVICES had the most reports" use device.generic_name.exact (device type) or device.brand_name.exact (specific product).
limit	number	no	Buckets (1-100, default 20).

Build a bounded FDA regulatory snapshot for one device company across 510(k), PMA, recalls, and MAUDE. Dataset name matching is imperfect and MAUDE counts are signals, not safety rates.

Parameter	Type	Required	Notes
company	string	yes	Company/manufacturer name.
limit_per_dataset	number	no	Rows per dataset (1-20, default 5).

Look up FDA device classification and regulatory context by product code, device name, or regulation number. Classification describes the product-code category, not a specific product’s clearance or approval.

Parameter	Type	Required	Notes
product_code	string	no	—
device	string	no	—
regulation_number	string	no	—
limit	number	no	Rows (1-100, default 20).

Search FDA GUDID/UDI records by brand, company, device identifier, or product code. A UDI record describes an identified device in GUDID; it does not establish current sales, availability, clearance, approval, or safety.

Parameter	Type	Required	Notes
query	string	no	Brand or device description.
company	string	no	—
primary_di	string	no	—
product_code	string	no	—
limit	number	no	—

Search FDA device registration/listing data by firm, registration number, product code, or listing number. Registration/listing does not mean FDA approval, clearance, certification, or endorsement.

Parameter	Type	Required	Notes
firm	string	no	—
registration_number	string	no	—
product_code	string	no	—
listing_number	string	no	—
limit	number	no	—

Build a bounded cross-dataset snapshot for one FDA product code: classification, recent 510(k)s, PMAs, recalls, and MAUDE reports. Dataset counts have different meanings; MAUDE counts are not event rates.

Parameter	Type	Required	Notes
product_code	string	yes	—
limit_per_dataset	number	no	—

Free

$0 forever

Every tool — any call limit is its publisher’s, not ours
No card, and mcprush charges nothing for it
Runs at its publisher’s own address — this marketplace is not in the path
Nothing to cap, because mcprush bills nothing

Nothing here is billable: mcprush charges nothing to install Fda Devices or to call it, at any volume.

Where are you running it?

Tool surface

Release history

Fda Devices MCP

What it does

Quickstart

Where are you running it?

Tool surface

What counts against your monthly calls

Release history

See also