Kent Design & Manufacturing, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Kent Design & Manufacturing, Inc.” (first 1986, latest 1986), across 1 product code in 1 review panel. Median 510(k) review time under this name: 12 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 | 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 |
|---|---|---|---|
| IKK | System, Isokinetic Testing And Evaluation | 6 | 6 |
Review panels
Most recent Kent Design & Manufacturing, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K862998 | PORTABLE ISOKINETICS 3007 BACK/ABDOMEN UNIT | IKK | 1986-08-20 | 12 |
| K862997 | PORTABLE ISOKINETICS 3005 HIP UNIT | IKK | 1986-08-20 | 12 |
| K862996 | PORTABLE ISOKINETICS 3004 KNEE UNIT | IKK | 1986-08-20 | 12 |
| K862995 | PORTABLE ISOKINETICS 3003 SHOULDER UNIT | IKK | 1986-08-20 | 12 |
| K862994 | PORTABLE ISOKINETICS 3002 ISO KANE II | IKK | 1986-08-20 | 12 |
| K862993 | PORTABLE ISOKINETICS 3001 WRIST/ANKLE UNIT | IKK | 1986-08-20 | 12 |
Recalls
openFDA lists no recalls under a recalling firm named Kent Design & Manufacturing, 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Kent Laboratories, Inc. (40 510(k)s)
- Kent Imaging, Inc. (5 510(k)s)
- Kent Barker & Assoc. (1 510(k)s)
- Kent J. Toone, D.D.S. (1 510(k)s)
- Kent Medical Devices, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Kent Design & Manufacturing, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Kent Design & Manufacturing, Inc.” (first 1986, latest 1986), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Kent Design & Manufacturing, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kent Design & Manufacturing, Inc. is 12 days.
Which FDA product codes appear under Kent Design & Manufacturing, Inc.?
The most frequent FDA product codes under this applicant name are IKK (System, Isokinetic Testing And Evaluation, 6).
Next steps
- See all 6 Kent Design & Manufacturing, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IKK, Kent Design & Manufacturing, 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.