How It Works — AIFDA Intel

Every FDA source, continuously parsed

We ingest every public FDA dataset that touches AI devices — daily.

The 510(k) database, De Novo grants, openFDA, MAUDE adverse event reports, the guidance docket, and enforcement records. Each syncs on the schedule FDA updates it, so there is no lag between FDA publishing and you knowing.

510(k) database syncs daily against FDA's release
Guidance docket polled continuously for new and revised documents
Enforcement actions and warning letters captured same-day
MAUDE adverse event reports indexed and linked to device records

Sync log

510(k) DB — synced 4 min ago · 950+ devices

De Novo — synced 4 min ago · 47 decisions

openFDA — synced 12 min ago

Guidance docket — synced 1 hr ago

MAUDE — sync in progress

Enforcement — synced 2 hr ago

Structure, tag, and connect

Raw records become a connected dataset. Every field tagged, every link resolved.

A cleared 510(k) is not useful in isolation. AIFDA Intel tags each device with its indication, algorithm type, device class, and clearance track — then resolves its predicate chain, links it to every guidance document that applies to its product code, and flags relevant enforcement history.

Every device tagged: indication, class, algorithm type, clearance track
Predicate chains resolved across multiple generations
Guidance documents cross-linked to the product codes they govern
PCCP records indexed and linked to the device that requested them

Device record · K243821

Indication: Stroke detection — ischemic

Algorithm: Deep learning classifier

Predicate: K213452 → K198344 → K180291

Guidance: 3 documents apply

PCCP: Approved May 2025

Enforcement: None on record

Search, filter, and explore

Query the full dataset in seconds. No spreadsheet, no manual search.

Filter 950+ cleared devices by any combination of indication, device class, algorithm type, clearance date, and product code. Trace predicates, compare clearance timelines, and pull competitive views of any indication — without opening a single PDF.

Multi-field filters across the full clearance database
Predicate graph explorer: trace any lineage forward or back
Indication-level competitive views with clearance velocity charts
Regulatory timeline builder from comparable device histories

Search results · "stroke detection AI"

K243821 — Viz.ai · Cleared Jan 2025

K231187 — Aidoc · Cleared Sep 2024

K219834 — RapidAI · Cleared Mar 2023

K208821 — [Redacted] · Cleared Nov 2022

14 results · sorted by date · filtered: Class II, DL

Alerts land before you go looking

The intelligence finds you. Set a watch list and we do the monitoring.

Watch product codes, indications, or specific competitors. When something moves — a clearance, a guidance update, a PCCP approval, an enforcement action — AIFDA Intel fires an alert the same day. Real-time on Professional and Enterprise; weekly digest on Startup.

Watch any product code, indication, or named company
Alerts fire on: competitor clears, new guidance, PCCP grants, enforcement
Real-time delivery (Pro+) or weekly digest (Startup)
Each alert links directly to the source record in the platform

Alert · just now

Competitor cleared — Aidoc, QMF product code

New guidance draft — AI transparency, comment period open

PCCP approved — algorithm retrain, QMF, DL classifier

Data Sources

Six public FDA datasets. One connected view.

Everything AIFDA Intel surfaces traces back to a primary FDA source. No proprietary claims, no extrapolation — just structured, connected public data.

510(k) Database

Every 510(k) clearance FDA has published, including AI/ML-enabled devices, summaries, and predicate references. Synced daily.

De Novo Database

All De Novo grants, with special controls and the product codes they established. The foundation of every AI device category.

openFDA

FDA's open API covering device classifications, recall events, adverse event reports, and enforcement actions at scale.

FDA Guidance Docket

Every published and draft guidance document relevant to AI/ML-enabled devices, from 2019 to today. Version-tracked.

MAUDE

The Manufacturer and User Facility Device Experience database — adverse event reports indexed and linked to cleared device records.

Enforcement Database

Warning letters, import alerts, and recall actions relevant to AI-enabled medical devices, summarized and cross-linked.

The Difference

What this replaces.

Without AIFDA Intel

✕Download FDA's static spreadsheet, open in Excel, filter manually — weekly, maybe
✕Search 510(k) database one record at a time to find predicates
✕Subscribe to FDA RSS, read every item, decide manually what's relevant
✕Miss a competitor clearance until someone mentions it in a meeting
✕Read every PCCP approval PDF in full to understand the pattern
✕Build a regulatory timeline by querying colleagues and guessing

With AIFDA Intel

✓Live, searchable database — filtered to your indication in seconds
✓Predicate graph explorer — full lineage, every generation, one click
✓Smart alerts — only what's relevant to your product codes and competitors
✓Real-time competitor alerts — know before the meeting
✓PCCP tracker — every approved plan indexed, patterns surfaced
✓Timeline builder — grounded in real comparable clearance histories

FDA publishes everything. We make it usable.