Peca Labs: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Peca Labs” (first 2018, latest 2024), across 1 product code in 1 review panel. Median 510(k) review time under this name: 105 days. Since 2017 the median was 105 days, against 143 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 | 131 |
| 2019 | 1 | 117 |
| 2020 | 1 | 105 |
| 2021 | 0 | — |
| 2022 | 1 | 59 |
| 2023 | 0 | — |
| 2024 | 1 | 51 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Peca Labs took a median 105 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 143 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 5 | 5 |
Review panels
- Cardiovascular (5)
Most recent Peca Labs 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233783 | exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts | DSY | 2024-01-17 | 51 |
| K221628 | exGraft, exGraft Carbon | DSY | 2022-08-04 | 59 |
| K202471 | exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft | DSY | 2020-12-11 | 105 |
| K183613 | exGraft, exGraft Carbon | DSY | 2019-04-22 | 117 |
| K180957 | exGraft, exGraft Carbon ePTFE Vascular Grafts | DSY | 2018-08-21 | 131 |
Recalls
openFDA lists no recalls under a recalling firm named Peca Labs.
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.
Device clinical trials
An industry sponsor named Peca Labs is the lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT05452720: MASA Valve Early Feasibility Study (Recruiting, started 2023-05-18)
Frequently asked questions
How many FDA 510(k) clearances are listed under Peca Labs?
FDA lists 5 510(k) clearances under the applicant name “Peca Labs” (first 2018, latest 2024), across 1 product code 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 Peca Labs?
The median time from FDA receipt to decision across 510(k)s cleared under the name Peca Labs is 105 days. Since 2017: 105 days, versus 143 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Peca Labs?
The most frequent FDA product codes under this applicant name are DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter, 5).
Next steps
- See all 5 Peca Labs clearances with predicates and recalls
- Run predicate analysis for product code DSY, Peca Labs'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.