Procyte Corp.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Procyte Corp.” (first 1996, latest 1998), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 150 days. 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | 5 | 5 |
| KMF | Bandage, Liquid | 4 | 4 |
Review panels
Most recent Procyte Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K971612 | OSMO/PCA PILLOW WOUND DRESSING | KMF | 1998-03-16 | 318 |
| K972329 | OSMOCYTE RA WOUND DRESSING | KMF | 1997-12-10 | 170 |
| K972150 | OSMOCYTE ISLAND WOUND DRESSING | KMF | 1997-12-10 | 184 |
| K970153 | LAMIN-2 HYDRATING GEL | MGQ | 1997-06-05 | 140 |
| K965143 | OSMOCYTE WOUND MANAGER SHEET DRESSING | MGQ | 1997-05-22 | 150 |
| K965005 | IAMIN IMPREGNATED GAUZE DRESSING | MGQ | 1997-02-24 | 70 |
| K964468 | IAMIN WET DRESSING (COPPER-SALINE) | MGQ | 1997-02-03 | 89 |
| K962623 | OSMOCYTE ULTRA/PE PILLOW WOUND DRESSING | KMF | 1996-11-26 | 144 |
| K953853 | IAMIN GEL WOUND DRESSING | MGQ | 1996-02-05 | 173 |
Recalls
openFDA lists no recalls under a recalling firm named Procyte Corp..
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 Procyte Corp.?
FDA lists 9 510(k) clearances under the applicant name “Procyte Corp.” (first 1996, latest 1998), 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 Procyte Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Procyte Corp. is 150 days.
Which FDA product codes appear under Procyte Corp.?
The most frequent FDA product codes under this applicant name are MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic, 5); KMF (Bandage, Liquid, 4).
Next steps
- See all 9 Procyte Corp. clearances with predicates and recalls
- Run predicate analysis for product code MGQ, Procyte Corp.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.