Unified 510(k) search
One search across 175,000+ clearances. 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, cross-referenced with adverse-event and recall data — 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
Every device category is cross-referenced with FDA MAUDE adverse events and recalls, then scored LOW, MODERATE, ELEVATED, or HIGH.
LOWMODERATEELEVATEDHIGH
Competitor alerts
Track a manufacturer and get an email the moment they clear a new device. 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 official FDA data. Updated monthly.
Pricing
Plans that pay for themselves in one saved afternoon.
Starter
For the occasional submission.
$99/mo
- Unified 510(k) search
- Basic filters (product code, manufacturer, date)
- 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
- Computed review timelines
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.
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.