1,614
FDA authorization records
Decisions from September 1995 through June 29, 2026.
Regulatory market snapshot
What the FDA list shows
The FDA AI-enabled medical device list contains 1,614 authorization records in the file retrieved October 15, 2026, with decisions through June 29, 2026. These include 510(k) clearances, De Novo grants, and premarket approvals or supplements. The list describes regulatory authorizations; it does not measure sales, utilization, installed units, or all AI capabilities on the market.
The analysis adds current product-code class, lead panel, and a project-derived clinical-function category to each authorization record. The complete categorized table is available below.
96.2%
Cleared through 510(k)
1,553 of the 1,614 authorization records.
99.0%
Currently Class II
1,598 records, based on current primary-product-code class.
76.2%
Led by Radiology
1,230 records list Radiology as the lead panel.
Approval profile
Pathways, current risk classifications, and lead panels
Each chart counts FDA AI-list authorization records. Device class reflects the current openFDA classification for each record’s primary product code.
Clinical use
What the devices are designed to do
Clinical function is a project-derived grouping based on FDA device names, product codes, and generic device types. It is intended to make the list easier to navigate; it is not an FDA-defined taxonomy.
Decision activity
FDA AI-list authorization records by decision year
The recent rise partly reflects growth in authorizations and changes in the scope and maintenance of the FDA public AI-enabled device list. The partial 2026 total runs through June 29, 2026.
Complete categorized inventory
Explore all 1,614 FDA AI-list authorization records
Search by device, company, submission number, product code, or function; then narrow by pathway, current class, lead panel, clinical function, or decision year.
Download complete device data (CSV)16 source and analytical fields
Authorization records
| Decision date | Device and applicant | Pathway | Current class | Lead panel | Clinical function | Submission |
|---|
Methodology
Scope, definitions, and sources
FDA authorization record
One row on the FDA AI-enabled medical device list, representing a 510(k) clearance, De Novo grant, or premarket approval (PMA).
Current device class
The current class attached to the record’s primary product code in openFDA’s device classification data. It is not necessarily the device class on the original decision date.
Lead panel
The FDA medical-specialty panel associated with the primary product code. Devices within a panel may be used in more than one clinical setting.
Clinical function
A project-derived product-family category based on device name, primary product code, and generic device type. It is analytical metadata, not an FDA designation.
Primary sources
Snapshot and reproducibility
Device and classification data were retrieved October 15, 2026; the FDA list includes decisions through June 29, 2026. The classification source was last updated 2026-10-05. Clinical-function mappings are retained only where the prior reviewed device identity is unchanged. The separate recalls view retains its August 2026 source snapshot.
Postmarket safety context
AI Medical Device Recalls
The analysis identified 271 product recall records grouped into 149 distinct recall events and linked through native FDA identifiers to 102 authorization records on the FDA AI-enabled medical device list. Those authorization records represent 91 normalized device-name strings.
A recall event is the broader FDA action. It can include several affected products or configurations, each with its own recall number. Separately, the same product or FDA authorization can be associated with multiple recall events over time.
271
Product recall records
Individual recall-number records in the strict match set.
149
Distinct recall events
The event-level denominator used for cause percentages.
102
AI-list authorization records
Strictly linked through native FDA identifiers.
40
Multi-record recall events
Forty events had multiple matched product records; 109 had one.
Why devices were recalled
AI medical device recall causes
Cause percentages are calculated from 149 distinct recall events, with each event counted once regardless of the number of product recall records.
Recall measures
Recall events, product records, and device authorizations
The 271 product recall records belong to 149 distinct recall events and link to 102 FDA authorizations. Those authorizations include 91 distinct device names after name standardization.
01
Recall event
The overall FDA recall action, identified by an event number. One event may span multiple products.
02
Product recall record
An individual recall-number record describing a particular product, model, configuration, or distribution scope.
03
AI-list authorization record
An FDA decision record on the AI-enabled device list. One authorization may be linked to multiple recall events.
04
Device-name string
A normalized name used for descriptive counting. Several authorization records can share the same device name.
Affected authorization records
Search recalled AI-enabled medical devices
The table lists all 102 FDA AI-list authorization records in the strict identifier-linked recall set. Counts show how many product recall records and distinct recall events were connected to each authorization.
AI-list authorization records with identifier-linked recalls
| Device and applicant | Decision date | Current class | Lead panel | Product recall records | Distinct recall events | Submission |
|---|
Methodology
How the AI medical device recalls were identified
Strict identifier linkage
The headline set requires native FDA identifiers connecting a recall record to an authorization on the FDA AI-enabled medical device list. A similar device name, manufacturer, or product code alone was not sufficient.
Recall event and product record
An event is the broader FDA recall action. An event may contain multiple recall-number product records. Each event is counted once when calculating cause percentages.
Cause assignment
Each of the 149 events received one normalized cause based on FDA’s reason-for-recall and root-cause fields. The categories summarize the record and do not infer an undocumented cause.
Product-code and timing differences
Seven linked records had product-code mismatches, and five links predated the associated AI-list authorization. These records remain in the results because they match FDA authorization identifiers despite the product-code or date differences.
Data coverage
The analysis identifies recalls linked to FDA-listed AI-enabled devices. These links alone do not establish an AI-related cause or confirm that every recalled version included AI functionality. The FDA list is not a complete inventory of all AI-enabled devices on the market.
Sources and snapshot
The FDA AI-enabled device and classification data were retrieved August 20, 2026. The openFDA recall export was dated August 18, 2026.