Carrington Laboratories, Inc.: FDA clearances and approvals
Carrington Laboratories, Inc. has 15 FDA 510(k) clearances (first 1989, latest 2002), across 3 product codes in 2 review panels. Median 510(k) review time: 85 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 |
|---|---|---|---|
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | 7 | 7 |
| OLR | Oral Wound Dressing | 5 | 5 |
| FRO | Dressing, Wound, Drug | 3 | 3 |
Review panels
- General and Plastic Surgery (10)
- Dental (5)
Most recent Carrington Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K022670 | CARRAKLENZ AND ULTRAKLENZ | FRO | 2002-10-17 | 66 |
| K012126 | THE SALICEPT ORAL PATCH | OLR | 2001-10-03 | 89 |
| K983182 | ALOE THERAPY ORAL RINSE | OLR | 1998-12-10 | 90 |
| K964852 | RADIACARE ORAL WOUND RINSE | OLR | 1997-03-03 | 90 |
| K962218 | CARRASYN HYDROGEL WOUND DRESSING,CARRAGAUZE PADS,CARRAGAUZE STRIPS,CARRASORB M FDG | MGQ | 1996-09-12 | 94 |
| K961758 | CARASYN HYDROGEL WOUND PRODUCTS | MGQ | 1996-07-11 | 69 |
| K960428 | CARRASYN HYDROGEL WOUND DRESSING/FDG PADS/CARAGAUZE STRIPS/PADS (MODIFICATION) | MGQ | 1996-03-21 | 69 |
| K953423 | CASRRASYN ORAL WOUND DRESSING | OLR | 1995-10-11 | 113 |
| K951417 | CARRASYN HYDROGEL WOUND DRESSING, FDG PADS, CARRAGAUZE PADS, STRIPS | MGQ | 1995-05-10 | 43 |
| K944427 | CARRASYN FDG | MGQ | 1994-11-29 | 78 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Carrington Laboratories, 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 Carrington Laboratories, Inc. have?
Carrington Laboratories, Inc. has 15 FDA 510(k) clearances (first 1989, latest 2002), across 3 product codes in 2 review panels.
How long does FDA take to clear Carrington Laboratories, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Carrington Laboratories, Inc.'s cleared 510(k)s is 85 days.
What devices does Carrington Laboratories, Inc. make?
Its most frequent FDA product codes are MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic, 7); OLR (Oral Wound Dressing, 5); FRO (Dressing, Wound, Drug, 3).
Has Carrington Laboratories, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Carrington Laboratories, Inc. Related entities may recall under other names.
Next steps
- See all 15 Carrington Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MGQ, Carrington Laboratories, 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.