Data
How current is the 510(k) data?

Predicase syncs from openFDA daily. New clearances appear within 24 hours of FDA publishing them. You're always searching live data — not a quarterly export.

Does Predicase cover all 510(k) clearances?

Yes — all 142,000+ clearances going back to the 1970s are indexed. Data comes directly from the FDA's openFDA API and is updated continuously.

Does this replace the FDA's official 510(k) database?

No — Predicase is a search and organization layer on top of FDA's public data. Every record links back to the official FDA source. We make the data easier to find and compare; we don't replace it.

Workflow
Can I use Predicase with multiple clients at once?

Yes. Create a named project for each client engagement. Starter supports 3 active projects. Pro is unlimited. Switch between projects from the sidebar.

Can I export predicate summaries for my submission package?

Yes — that's one of the core use cases. Generate a structured PDF from any predicate detail page. Starter gets 5 exports per month. Pro gets unlimited branded exports.

Does the comparison view show differences automatically?

Yes. When you add two or three predicates to a comparison, any field that differs across them is marked with a gold stripe. No manual highlighting needed.

Privacy & Security
Do you store my submission data?

Predicase stores your saved projects and shortlists — which are just lists of K-numbers you've bookmarked. We don't store any submission documents, device specifications, or client information you don't explicitly enter.

Is Predicase HIPAA compliant?

Predicase doesn't process protected health information. The FDA 510(k) database is public regulatory data. No PHI is involved in predicate research.

Billing
What does the 14-day free trial include?

Full Pro access — no watermarks, no caps. Credit card required up-front. We email you the day before your trial converts. Cancel in two clicks from your dashboard.

Can I cancel anytime?

Yes. Cancel from your account dashboard at any time. No cancellation fee. Access continues until the end of your current billing period.

Do you offer annual billing?

Yes — 20% off Starter and Pro billed annually. Email hello@predicase.com to switch. We'll prorate your current month.

Everything you need for a 510(k) submission. Nothing you don't.

14-day free trial. No setup. Cancel anytime.

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