Sample 510(k) Report
A handheld pain relief laser
A whole report, as a buyer receives it: 17 pages, for a real device FDA cleared on Dec 12, 2025. We wrote the request from its public summary with every name and number left out, and used only FDA records from before the day FDA received its 510(k). The last page compares the report with what FDA decided.
How it held up
| The report said | What happened | |
|---|---|---|
| Product code | NHN, with ILY and GEX as alternates | Classified under NHN |
| Predicate | Claim K241057, ranked first of the 83 devices it read | The company claimed K241057 |
| Review time | Median 114 days, across 271 filings in 5 years | 143 days |
The device is K252273, from Dmc Importação E Exportação DE Equipamentos Ltda. One device is one result, not a hit rate. The company did not commission or review this report.
What is inside
- Your device, as we read it
- Classification and pathway
- Ranked candidate predicates
- Side-by-side comparison
- What FDA saw from these devices
- Family-tree risk
- Review-time outlook
- Post-market record
- Assessment and next steps
- What applies either way
- Sources and method