Combe, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under 2 spellings of the applicant name “Combe, Inc.” (first 1977, latest 2017), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 84 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 | 1 | 141 |
| 2015 | 1 | 52 |
| 2016 | 0 | — |
| 2017 | 1 | 30 |
| 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 Combe, Inc. took a median 30 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 |
|---|---|---|---|
| NUC | Lubricant, Personal | 3 | 3 |
| EFT | Cleanser, Denture, Over The Counter | 2 | 2 |
| EHS | Cushion, Denture, Over The Counter | 1 | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
| KXX | Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer | 1 | 1 |
| KYS | Insoles, Medical | 1 | 1 |
Review panels
- Dental (4)
- Obstetrics and Gynecology (3)
- General Hospital (2)
Most recent Combe, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K171855 | External Moisturizing Gel | NUC | 2017-07-21 | 30 |
| K150615 | Vaginal Moisturizing Gel | NUC | 2015-05-01 | 52 |
| K141718 | INTERNAL HYDRATING GEL | NUC | 2014-11-13 | 141 |
| K942203 | OTC DENTURE CLEANSER | EFT | 1994-08-10 | 97 |
| K925259 | CFR MONOGRAPH | EFT | 1993-01-11 | 84 |
| K863375 | SEA-BOND | KXX | 1986-09-19 | 16 |
| K780719 | FUNGUS FIGHTER INSOLES | KYS | 1978-10-10 | 162 |
| K770413 | CUSHIONS, DENTURE ADHESIVE, ALL-DAY | EHS | 1977-06-24 | 112 |
| K770175 | SEA-BOND ADHEVISE DENTURE CUSHIONS | KKX | 1977-02-04 | 9 |
Recalls
openFDA lists no recalls under a recalling firm named Combe, 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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Combe, Inc. (6)
- Combe Incorporated (3)
Frequently asked questions
How many FDA 510(k) clearances are listed under Combe, Inc.?
FDA lists 9 510(k) clearances under 2 spellings of the applicant name “Combe, Inc.” (first 1977, latest 2017), across 6 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 Combe, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Combe, Inc. is 84 days.
Which FDA product codes appear under Combe, Inc.?
The most frequent FDA product codes under this applicant name are NUC (Lubricant, Personal, 3); EFT (Cleanser, Denture, Over The Counter, 2); EHS (Cushion, Denture, Over The Counter, 1).
Next steps
- See all 9 Combe, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NUC, Combe, 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 (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.