AI/ML Clearance Database
950+ FDA-cleared AI and ML devices, fully structured and tagged. The static spreadsheet FDA publishes becomes a queryable database with every field that matters for regulatory strategy.
- Filter by indication, device class, panel, and algorithm type
- Sort by clearance date to see velocity in any category
- Open any device to its summary, predicate chain, and product code
For illustrative purposes only. Data shown is not real.
Predicate Intelligence
Find which AI devices are being used as predicates, and how often. Built on the same infrastructure as Predicase, it turns the predicate graph into a strategy tool.
- See predicate frequency for any cleared AI device
- Trace the full predicate lineage of an indication
- Identify which predicates clear fastest
For illustrative purposes only. Data shown is not real.
PCCP Tracker
The only tool tracking Predetermined Change Control Plans. Know exactly which algorithm changes FDA accepts without requiring a new 510(k) — before you commit to an ML pipeline.
- Every approved PCCP, indexed by device and product code
- Pattern analysis on what modification protocols FDA accepts
- Alerts when a PCCP is approved in your indication
For illustrative purposes only. Data shown is not real.
De Novo Monitor
Track the De Novo decisions that create entirely new AI product codes. These define the regulatory categories your competitors — and you — will clear into for years.
- Every De Novo grant that established an AI product code
- Special controls and classification context, summarized
- Links to the resulting downstream 510(k) clearances
For illustrative purposes only. Data shown is not real.
FDA Guidance Monitor
Every AI-related FDA guidance, draft, action plan, and discussion paper in one place — connected to the device-level data each one governs. Plain-English summaries included.
- Full library from 2019 to today, version-tracked
- Plain-English summary of what each document changes
- Cross-links from guidance to the product codes it affects
For illustrative purposes only. Data shown is not real.
Competitive Intelligence
See who dominates each AI indication. First-mover analysis, clearance velocity, and investor-grade charts turn public 510(k) summaries into a competitive map.
- Market-share view by indication and product code
- Clearance velocity benchmarked against the category
- Exportable charts for board decks and diligence memos
For illustrative purposes only. Data shown is not real.
Enforcement & Warning Letter Monitor
Watch FDA's enforcement posture on AI devices as it develops. Warning letters and enforcement actions are surfaced and tied to the products and indications they touch.
- Warning letters relevant to AI/ML devices, summarized
- Trend view of enforcement focus over time
- Early-warning alerts on emerging enforcement themes
For illustrative purposes only. Data shown is not real.
MAUDE Adverse Event Monitor
Track adverse event reports for AI-enabled devices in MAUDE, connected to the cleared device records. Spot signal before it becomes an enforcement story.
- Adverse event reports mapped to specific cleared devices
- Volume trends by device and indication
- Alerts on unusual report activity in your space
For illustrative purposes only. Data shown is not real.
Smart Alerts
Get notified the moment something moves: a competitor clears, FDA publishes new guidance for your product code, or a PCCP is approved in your space. Real-time on Professional and above.
- Watch specific product codes, indications, or competitors
- Real-time, daily, or weekly digest delivery
- Routes to email today, Slack and webhooks on the roadmap
For illustrative purposes only. Data shown is not real.
Regulatory Timeline Builder
Estimate your path to clearance from the histories of similar cleared devices. Build a defensible timeline grounded in what actually happened in your category.
- Timeline estimates derived from comparable clearances
- Adjust for device class, predicate, and review track
- Export a milestone view for planning and diligence
For illustrative purposes only. Data shown is not real.