Unified 510(k) + PMA search
One search across 230,000+ records — 175,000+ 510(k) clearances and 56,000+ PMA approvals. Filter by product code, manufacturer, decision date, and advisory committee — no tab-switching.
FDA 510(k) regulatory intelligence
FDA predicate research, in minutes instead of hours.
SignalIQ searches 175,000+ FDA 510(k) clearances — plus 56,000+ PMA approvals and device classifications — each cross-referenced with recall and adverse-event history, so you can find defensible predicates without the manual cross-checking.
Get early accessFree during early access. No credit card.
The problem
Predicate research still runs on three clunky government portals.
Scattered across three FDA databases
Clearances live in the 510(k) database, failures in MAUDE, recalls in a third system. None of them talk to each other.
Clearances aren't linked to failure history
The free FDA interface will hand you a predicate without ever telling you it was later recalled or racked up adverse events.
Manual research eats hours per submission
Cross-checking by hand is slow, and at $300–400 an hour those hours land on the invoice — yours or your client's.
What it does
The cross-checking, already done.
Risk signals
7,000+ device categories cross-referenced with FDA MAUDE adverse events and recall severity (Class I/II/III), then scored LOW, MODERATE, ELEVATED, or HIGH.
LOWMODERATEELEVATEDHIGH
Competitor alerts
Track a manufacturer and get an email the moment they clear a new device — and browse their full 510(k) and PMA history in one timeline. Stop manually re-running the same searches every week.
Computed review timelines
Average days-to-decision per product code — a planning benchmark the raw FDA data never exposes on its own.
Built from 175,000+ 510(k) clearances, 56,000+ PMA records, and 58,000+ recalls across 34,000+ manufacturers (1976–2026) — official FDA data, refreshed monthly.
Pricing
Plans that pay for themselves in one saved afternoon.
Starter
For the occasional submission.
$99/mo
- Unified 510(k) + PMA search
- Basic filters (product code, manufacturer, date)
- Recall & adverse-event history on every result
- Export results to CSV
- Single seat
Most popular
Pro
For working regulatory professionals.
$299/mo
- Everything in Starter
- Risk signals (MAUDE + recall scoring)
- Competitor alerts
- AI category summaries
- Category risk breakdowns (recall, adverse-event & device-class)
- Computed review timelines (avg. days to decision)
Investor / Enterprise
For teams and analysts.
$999/mo
- Everything in Pro
- Portfolio & market analytics
- API access
- Multi-seat with shared workspaces
- Priority support
Prices in USD. Early users get founder pricing locked in.
Need a custom plan, or have questions before you commit? Email our team at sales@signaliq.alchimiam.com
Early access
Get early access to SignalIQ.
Tell us where to reach you. We'll send an invite as we open up the early-access group.
No spam. Early users get founder pricing locked in.