Promedica Products, Inc.: FDA clearances and approvals
Promedica Products, Inc. has 6 FDA 510(k) clearances (first 1988, latest 1992), across 5 product codes in 3 review panels. Median 510(k) review time: 120 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FXX | Mask, Surgical | 2 | 2 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 | 1 |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | 1 | 1 |
| GAS | Suture, Nonabsorbable, Synthetic, Polyester | 1 | 1 |
| LZA | Polymer Patient Examination Glove | 1 | 1 |
Review panels
Most recent Promedica Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K913101 | PETERS CARDIOFLON(TM) SUTURE | GAS | 1992-08-12 | 397 |
| K913102 | PETERS CARDIONYL(TM) SUTURE | GAR | 1992-08-03 | 388 |
| K892768 | PATIENT EXAMINATION GLOVES (POLY) | LZA | 1989-06-14 | 64 |
| K883412 | THE CARPENTIER TRANS-MITRAL VENTRICULAR VENT(TM) | DWF | 1989-02-08 | 177 |
| K882883 | C-MASK(FLAT) | FXX | 1988-08-10 | 30 |
| K882882 | C-MASK | FXX | 1988-08-10 | 30 |
Recalls
openFDA lists no recalls under a recalling firm named Promedica Products, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Promedica Products, Inc. have?
Promedica Products, Inc. has 6 FDA 510(k) clearances (first 1988, latest 1992), across 5 product codes in 3 review panels.
How long does FDA take to clear Promedica Products, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Promedica Products, Inc.'s cleared 510(k)s is 120 days.
What devices does Promedica Products, Inc. make?
Its most frequent FDA product codes are FXX (Mask, Surgical, 2); DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 1); GAR (Suture, Nonabsorbable, Synthetic, Polyamide, 1).
Has Promedica Products, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Promedica Products, Inc. Related entities may recall under other names.
Next steps
- See all 6 Promedica Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FXX, Promedica Products, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.