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 175,000+ 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.

Where does the MAUDE adverse event data come from?

MAUDE data comes directly from FDA's public adverse event reporting database. It covers 10M+ reports going back decades. Predicase surfaces MAUDE records alongside 510(k) clearances so you can check a predicate's post-market safety history without leaving the app. Available on Pro and Intelligence plans.

Workflow
Can I use Predicase with multiple clients at once?

Yes. Create a named project for each client engagement. Starter supports 1 active project. Pro and Intelligence are 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 3 exports per month. Pro and Intelligence get unlimited branded exports with your firm name.

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.

What does the predicate chain visualizer show?

Every 510(k) was cleared based on a predicate — which itself was cleared based on an earlier predicate. The chain visualizer traces that lineage generation by generation, so you can see how far back the chain goes and identify any weak links before you file. Available on the Intelligence plan.

What warning letter data does Intelligence include?

Intelligence surfaces FDA warning letters by manufacturer so you can see whether a predicate's applicant has an enforcement history. You can search by manufacturer, product type, and violation category directly from Predicase.

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?

14 days on the Starter plan — full access, no watermarks, no caps. No credit card required to start. Upgrade to Pro or Intelligence at any time. Cancel in two clicks from your account dashboard.

What is the difference between Pro and Intelligence?

Pro adds MAUDE adverse event monitoring on top of the core search, compare, and export features. Intelligence adds FDA warning letter history and the predicate chain visualizer — for consultants who need the full regulatory picture before committing to a predicate.

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.

How does annual billing work?

Annual billing saves 25% across all plans — Starter drops to $149/mo, Pro to $299/mo, and Intelligence to $499/mo, all billed as a single annual payment. You can switch to annual from your account dashboard at any time and we'll prorate your current month.

Do you offer a startup discount?

Yes — 50% off Pro for 12 months for medical device startups pre-revenue or under $2M ARR. Email hello@predicase.com from your company address and we'll set it up within one business day.

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

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

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