Kentron Health Care, Inc.: FDA clearances and approvals
Kentron Health Care, Inc. has 6 FDA 510(k) clearances (first 1995, latest 2003), across 5 product codes in 3 review panels. Median 510(k) review time: 102 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 |
|---|---|---|---|
| FYC | Gown, Isolation, Surgical | 2 | 2 |
| EFQ | Gauze/Sponge, Internal | 1 | 1 |
| FLK | Thermometer, Clinical Mercury | 1 | 1 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 1 | 1 |
| HIB | Speculum, Vaginal, Nonmetal | 1 | 1 |
Review panels
Most recent Kentron Health Care, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K030693 | KENTEX DISPOSABLE VAGINAL SPECULUM | HIB | 2003-08-27 | 175 |
| K972410 | IMPERVIOUS ISOLATION GOWN | FYC | 1997-09-19 | 85 |
| K971917 | KENTRON'S ISOLATION GOWN | FYC | 1997-09-19 | 119 |
| K953465 | KENTEMP | FLK | 1995-12-15 | 144 |
| K953914 | KENTEX | EFQ | 1995-11-06 | 77 |
| K953830 | KENSORB | GDY | 1995-10-03 | 48 |
Recalls
openFDA lists no recalls under a recalling firm named Kentron Health Care, 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 Kentron Health Care, Inc. have?
Kentron Health Care, Inc. has 6 FDA 510(k) clearances (first 1995, latest 2003), across 5 product codes in 3 review panels.
How long does FDA take to clear Kentron Health Care, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Kentron Health Care, Inc.'s cleared 510(k)s is 102 days.
What devices does Kentron Health Care, Inc. make?
Its most frequent FDA product codes are FYC (Gown, Isolation, Surgical, 2); EFQ (Gauze/Sponge, Internal, 1); FLK (Thermometer, Clinical Mercury, 1).
Has Kentron Health Care, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Kentron Health Care, Inc. Related entities may recall under other names.
Next steps
- See all 6 Kentron Health Care, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FYC, Kentron Health Care, 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.