Peek Health, S.A.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Peek Health, S.A.” (first 2018, latest 2025), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 100 days. Since 2017 the median was 100 days, against 131 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 1 | 45 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 108 |
| 2023 | 0 | — |
| 2024 | 1 | 246 |
| 2025 | 4 | 98 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Peek Health, S.A. took a median 100 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 131 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QIH | Automated Radiological Image Processing Software | 4 | 4 |
| LLZ | System, Image Processing, Radiological | 3 | 3 |
Review panels
- Radiology (7)
Most recent Peek Health, S.A. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252856 | PeekMed web | QIH | 2025-12-22 | 104 |
| K252452 | PeekMed web | QIH | 2025-11-12 | 100 |
| K251096 | PeekMed web | QIH | 2025-07-14 | 95 |
| K250042 | PeekMed web | QIH | 2025-03-19 | 70 |
| K240926 | PeekMed web | LLZ | 2024-12-06 | 246 |
| K222767 | PeekMed web (v1) | LLZ | 2022-12-30 | 108 |
| K182464 | PeekMed | LLZ | 2018-10-25 | 45 |
Recalls
openFDA lists no recalls under a recalling firm named Peek Health, S.A..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Peek Health, S.A.?
FDA lists 7 510(k) clearances under the applicant name “Peek Health, S.A.” (first 2018, latest 2025), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Peek Health, S.A.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Peek Health, S.A. is 100 days. Since 2017: 100 days, versus 131 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Peek Health, S.A.?
The most frequent FDA product codes under this applicant name are QIH (Automated Radiological Image Processing Software, 4); LLZ (System, Image Processing, Radiological, 3).
Next steps
- See all 7 Peek Health, S.A. clearances with predicates and recalls
- Run predicate analysis for product code QIH, Peek Health, S.A.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.