Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Peek Health, S.A. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
100 daysmedian FDA review time
246 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252856 | PeekMed web | Peek Health, S.A. | 2025-12-22 | 104 | 0 |
| K252452 | PeekMed web | Peek Health, S.A. | 2025-11-12 | 100 | 0 |
| K251096 | PeekMed web | Peek Health, S.A. | 2025-07-14 | 95 | 0 |
| K250042 | PeekMed web | Peek Health, S.A. | 2025-03-19 | 70 | 0 |
| K240926 | PeekMed web | Peek Health, S.A. | 2024-12-06 | 246 | 0 |
| K222767 | PeekMed web (v1) | Peek Health, S.A. | 2022-12-30 | 108 | 0 |
| K182464 | PeekMed | Peek Health, S.A. | 2018-10-25 | 45 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda