Covalontechnologies, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Covalontechnologies, Inc.” (first 2005, latest 2017), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 218 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 | 2 | 150 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 266 |
| 2016 | 0 | — |
| 2017 | 1 | 269 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Covalontechnologies, Inc. took a median 269 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 198 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | 3 | 3 |
| EZL | Catheter, Retention Type, Balloon | 1 | 1 |
| KGN | Wound Dressing With Animal-Derived Material(S) | 1 | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
Review panels
Most recent Covalontechnologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K163556 | MediClear PreOp | KKX | 2017-09-14 | 269 |
| K150550 | SilverCoat Silicone Foley Catheter | EZL | 2015-11-24 | 266 |
| K121819 | SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER | FRO | 2012-08-13 | 53 |
| K112549 | IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER | FRO | 2012-05-04 | 246 |
| K043296 | COLACTIVE AG COLLAGEN WITH SILVER ANTIMICROBIAL DRESSING | FRO | 2005-06-06 | 189 |
| K050177 | COLACTIVE COLLAGEN WOUND DRESSING | KGN | 2005-04-27 | 91 |
Recalls
openFDA lists no recalls under a recalling firm named Covalontechnologies, Inc..
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 Covalontechnologies, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Covalontechnologies, Inc.” (first 2005, latest 2017), across 4 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Covalontechnologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Covalontechnologies, Inc. is 218 days.
Which FDA product codes appear under Covalontechnologies, Inc.?
The most frequent FDA product codes under this applicant name are FRO (Dressing, Wound, Drug, 3); EZL (Catheter, Retention Type, Balloon, 1); KGN (Wound Dressing With Animal-Derived Material(S), 1).
Next steps
- See all 6 Covalontechnologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FRO, Covalontechnologies, Inc.'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.