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ANALYSIS · LIVE

510(k) Predicate Finder.

Enter your device details below to generate your predicate intelligence report.

Step 1

Describe Your Device

Tell us what your device is and what it does. The more specific you are, the better the analysis.

Device Description *

Describe your device in 2–3 sentences. What is it? What does it do?

Intended Use / Indications for Use *

Per FDA guidance, Intended Use and Indications for Use describe the device's general purpose and the specific clinical conditions under which it's intended to be used. For most modern 510(k) submissions, these are written as a single statement. Either form works here — describe what the device is for, who it's for, and the clinical context.

FDA Product Code (optional)

Enter your primary product code. For dual-classification devices you can list a secondary code separated by a comma (e.g. LEL, ISD) — the secondary expands the candidate-search pool, but the analysis narrative anchors on the primary. Full dual-classification handling is on the roadmap. Don't know your product code? Leave blank and we'll help identify it.

Validating against a cleared device? (optional)

Subject device K-number

If you're validating Keenr against a device you've already cleared, enter that device's K-number here. We'll exclude it from candidate retrieval.

Known predicate (optional)

If you already know predicates that should be considered, enter them here. They'll be added to the candidate pool regardless of what our retrieval surfaces.

Improve accuracy (optional)

Optional structured fields that map to FDA's substantial-equivalence dimensions. Filled values override what we'd otherwise extract from your Intended Use statement above. Leave blank to let the analysis infer them.

Patient Population

Intended Use Environment

Intended Users

Duration of Use

This is a modification of my own cleared device

Enables Special 510(k) pathway evaluation

This device uses AI or ML ( or )

Enables PCCP analysis, SaMD risk classification, and AI/ML regulatory assessment. Do not check if the device is not AI-enabled.