Kentec Medical, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Kentec Medical, Inc.” (first 1985, latest 2012), across 5 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 | 1 | 18 |
| 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 |
|---|---|---|---|
| FMT | Warmer, Infant Radiant | 2 | 2 |
| DRX | Electrode, Electrocardiograph | 1 | 1 |
| FPD | Tube, Feeding | 1 | 1 |
| FRW | Scale, Patient | 1 | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 | 1 |
Review panels
Most recent Kentec Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K120272 | AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SET | KNT | 2012-02-17 | 18 |
| K100526 | AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE | FPD | 2010-04-22 | 57 |
| K050443 | ACCU-LEAD | DRX | 2005-09-02 | 192 |
| K970686 | ACCUTEMP-PROBE | FMT | 1997-08-25 | 181 |
| K960080 | ACCUTEMP PROBE | FMT | 1996-05-01 | 111 |
| K853475 | GRAM-MA NEONATAL SC | FRW | 1985-09-05 | 16 |
Recalls
10 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2020-01-17.
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 Kentec Medical, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Kentec Medical, Inc.” (first 1985, latest 2012), across 5 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 Kentec Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kentec Medical, Inc. is 84 days.
Which FDA product codes appear under Kentec Medical, Inc.?
The most frequent FDA product codes under this applicant name are FMT (Warmer, Infant Radiant, 2); DRX (Electrode, Electrocardiograph, 1); FPD (Tube, Feeding, 1).
Next steps
- See all 6 Kentec Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FMT, Kentec Medical, 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.