What the 510(k) database contains
Every 510(k) premarket notification FDA has received — cleared, not substantially equivalent, or withdrawn — appears in the database with its K number, device name, applicant, product code, decision and decision date. For most clearances since the mid-1990s, FDA also publishes the 510(k) summary or statement, which describes the device, its intended use, and the evidence the sponsor submitted.
That summary is the strategic gold: it shows exactly what testing and comparison convinced FDA that a device was substantially equivalent to its predicate.
Four search strategies that work
- By product code — the most precise approach once you know your candidate code; it returns every clearance in that category.
- By device name — use clinical function words ('infusion pump', 'arrhythmia detection'), not brand names.
- By applicant — follow a competitor's regulatory history to see which codes and pathways they used.
- By K number — when a document cites a predicate's K number, pull it directly to read the summary.
Our free 510(k) search tool queries the same data by plain-language device description and returns K number, decision date, product code and decision type in one table.
How to read a clearance record
| Field | What it tells you |
|---|---|
| K number | The submission identifier; the year prefix tells you when it was received. |
| Decision and date | SE (substantially equivalent) means cleared; NSE means refused. The date anchors the predicate's age. |
| Product code | Confirms the category the clearance sits under — check it matches yours. |
| Clearance type | Traditional, Special or Abbreviated — hints at how the sponsor structured the submission. |
| 510(k) summary | Intended use, technological characteristics, and the performance evidence FDA accepted. |
Using predicates strategically
A predicate is not just a citation — it defines the comparison you must win. Choose a predicate whose intended use statement covers yours, whose technology is close enough that differences do not raise new questions of safety or effectiveness, and whose clearance is recent enough to reflect current FDA expectations.
- Collect two or three candidate predicates; the strongest intended-use match usually beats the newest clearance.
- Read each summary's testing section — it previews the bench, software and clinical evidence you will need.
- Watch for NSE decisions in your category: they reveal where FDA draws the line.
Pitfalls to avoid
- Assuming a cleared predicate guarantees your clearance — expectations tighten over time, especially for software and AI.
- Citing a predicate whose intended use is narrower than yours.
- Ignoring recall and adverse-event history for your candidate codes when judging category risk.
- Treating the database as the whole answer: special controls, guidance documents and recognized standards complete the picture.
Frequently asked questions
How far back should I search?
Start broad, then weight recent clearances. Predicates from the last ten years better reflect current evidence expectations, and very old clearances may rely on standards that have since been superseded.
What does 'SE' versus 'NSE' mean?
SE (substantially equivalent) means FDA cleared the device for marketing. NSE (not substantially equivalent) means FDA refused clearance — the sponsor typically needs a De Novo or PMA instead.
Can I cite more than one predicate?
Yes, multiple predicates are allowed, but one must be the primary predicate for the intended-use comparison. Splitting features across predicates is acceptable for technological characteristics, not for intended use.
How does MedTechCompass use this data?
The Regulatory Analyzer checks candidate product codes against clearance history so its pathway recommendation reflects whether real predicates exist for a device like yours — with links back to the source records.
Go deeper with MedTechCompass
Describe your device in plain language and get an AI-assisted triage: likely FDA class, product codes, premarket pathway, EU MDR and UK considerations — plus market attractiveness scoring across curated global markets.
This article is educational content from CAHIR Solutions and is not legal or regulatory advice. Regulatory decisions depend on your specific intended use and claims — confirm them with FDA resources, a qualified consultant, or a pre-submission meeting before filing.