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FDA medical device data: 510(k) clearances, De Novo, PMA approvals, recalls and registered establishments

FDA’s releasable 510(k) files, the PMA file, the product code classification and the openFDA device recall, enforcement and registration files, typed and joined on product code, 510(k) and PMA number and FEI number. 13 tables, about 2.2 million rows.

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Coverage: More than 175,000 cleared 510(k)s from 1976 to 2026 and about 490 granted De Novo requests from 1998. About 57,000 PMA rows: about 1,500 original applications and 56,000 supplements, for about 1,750 PMA numbers. All of FDA’s more than 7,000 product codes. About 59,000 recalled products from 23,000 recall events, and about 40,000 enforcement report entries from June 2012. About 26,000 registered establishments in about 110 countries under 22,000 owner/operators, with about 340,000 device listings and 1 million brand and model names.

Why pay for public data

FDA publishes this as five 510(k) text files, a PMA file, a classification file and openFDA JSON exports, each with its own keys and codes, and openFDA’s recall file adds every 510(k) that shares the recalled product’s code, up to about 2,900 on one recall. This package types every column, decodes the decision, panel and class codes, ties each recall to its enforcement class and to the 510(k) and PMA numbers the recall itself lists, and ties each listing to its establishment and product codes.

How it is built

  1. 1

    Pull FDA’s releasable 510(k) files, the PMA file and the product code classification file from accessdata.fda.gov, and the openFDA device recall, enforcement and registration and listing exports.

  2. 2

    Type every column, keep K numbers, PMA numbers, product codes and FEI numbers as text, decode codes with FDA’s code lists, and link recalls to enforcement reports, to the submissions they list and to registered establishments.

  3. 3

    Drop contact names, phones and emails, blank firm names that read as a personal name, and withhold personal emails and titled names in free text. Rebuilt monthly from the then-current FDA files.

What is in each record

FieldNotes
PRODUCT_CODE, DEVICE_NAME, DEVICE_CLASS, REVIEW_PANEL, REGULATION_NUMBERDEVICE_CLASSIFICATION: all of the more than 7,000 product codes, with IMPLANT, LIFE_SUSTAIN_SUPPORT and GMP_EXEMPT flags
N_510K, N_PMA_ORIGINAL, N_RECALLS, N_LISTINGS, N_ESTABLISHMENTSClearances, approvals, recalls and listings counted for each product code
K_NUMBER, APPLICANT, DECISION_DATE, DECISION_CODE, REVIEW_DAYSDEVICE_510K, with THIRD_PARTY_REVIEW and EXPEDITED_REVIEW. DEVICE_DE_NOVO mirrors it, keyed on DE_NOVO_NUMBER
PMA_NUMBER, SUPPLEMENT_NUMBER, IS_ORIGINAL, SUPPLEMENT_TYPE, SUPPLEMENT_REASON, AO_STATEMENTDEVICE_PMA: original applications and supplements, with the approval order statement
RECALL_NUMBER, RECALL_EVENT_ID, CLASSIFICATION, REASON_FOR_RECALL, ROOT_CAUSE_DESCRIPTIONDEVICE_RECALL: one row per recalled product. CLASSIFICATION on the roughly 40,000 rows with an enforcement report
VOLUNTARY_MANDATED, RECALL_INITIATION_DATE, CENTER_CLASSIFICATION_DATE, REPORT_DATEDEVICE_ENFORCEMENT: the weekly FDA Enforcement Report for devices
SUBMISSION_NUMBER, SUBMISSION_TYPE, IN_KITDEVICE_RECALL_SUBMISSION: about 51,000 rows tying recalls to the 510(k), De Novo and PMA numbers they list
ESTABLISHMENT_ID, FEI_NUMBER, ESTABLISHMENT_TYPES, ISO_COUNTRY_CODE, OWNER_OPERATOR_FIRM_NAMEDEVICE_ESTABLISHMENT: registered establishments, with the US agent’s business name
LISTING_ROW_ID, K_NUMBER, PMA_NUMBER, PROPRIETARY_NAMEDEVICE_LISTING, DEVICE_LISTING_PRODUCT and DEVICE_LISTING_NAME. LISTING_ROW_ID is a file position and changes each refresh
LKP_CODE, DATA_DICTIONARY67 decoded codes, and one row for each of the 250 columns

Who uses it

  • Regulatory affairs and medtech competitive intelligence teams
  • Supplier quality and procurement teams screening recall history
  • Medtech investors and market analysts

Pricing

$499 a year, including each monthly refresh.

No personal contact data is collected or sold in any QuestionPunk dataset.

Questions

Is this data not free from the government?
Yes. The source files are public and we link to them. You pay for the cleaning, the joins, the documented schema and the refresh, not for the data itself.
How is it delivered?
As Parquet or CSV files, by download link or to your own cloud bucket. The same tables load into Snowflake with the scripts we include.
Can I see the data before paying?
Yes. Ask for a sample and we send every row for the roughly 350 product codes in FDA’s Ophthalmic review panel, all years, about 94,000 rows, plus the full classification table and data dictionary.
Is a 510(k) clearance an FDA approval?
No. A 510(k) is cleared, a PMA is approved and a De Novo request is granted. FDA’s releasable 510(k) files hold cleared 510(k)s and granted De Novo requests only, so decisions such as not substantially equivalent or withdrawn are not in them.
Why do older recalls have no recall class?
The recall class comes from FDA enforcement reports, which start in June 2012. About 40,000 of the roughly 59,000 recall rows have one.
Does it include adverse events or device identifiers?
No. MAUDE adverse event reports, GUDID device identifiers, 510(k) summary PDFs, inspections and warning letters are not included. Product codes and 510(k) and PMA numbers join to GUDID if you have it.
Does it include personal data?
No. Contact names, phone numbers and emails are dropped. Firm names that read as a personal name are blanked and flagged, including about 560 510(k) applicants, and personal emails and names after a title in free text are withheld. The name screen is a heuristic, and FDA’s product names can still include a physician’s surname, for example in a surgeon’s custom procedure kit.
What is the license?
The accessdata.fda.gov files are US government works, which FDA’s website policies say are in the public domain unless marked otherwise. The openFDA files are released under CC0 1.0. Data provided by the U.S. Food and Drug Administration (https://open.fda.gov). FDA does not endorse this product.

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