R. Kent Richards, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “R. Kent Richards, Inc.” (first 1985, latest 1987), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 13 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 |
|---|---|---|---|
| JSI | Culture Media, Selective And Differential | 3 | 3 |
| JSJ | Culture Media, Selective And Non-Differential | 3 | 3 |
| KZI | Culture Media, Enriched | 2 | 2 |
| JSG | Culture Media, Non-Selective And Non-Differential | 1 | 1 |
| JSM | Culture Media, Non-Propagating Transport | 1 | 1 |
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | 1 | 1 |
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | 1 | 1 |
Review panels
- Microbiology (12)
Most recent R. Kent Richards, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K871065 | CHLAMYDIA & VIRAL TRANSPORT MEDIUM | JSM | 1987-04-14 | 27 |
| K854457 | COLUMBIA CNA AGAR W/5% SHEEP BLOOD | JSJ | 1985-11-18 | 13 |
| K854456 | CAMPYLOBACTER BLOOD AGAR | JSJ | 1985-11-18 | 13 |
| K854455 | CDC ANAEROBE BLOOD AGAR | JSG | 1985-11-18 | 13 |
| K854454 | TRYPTIC SOY BLOOD AGAR | KZI | 1985-11-18 | 13 |
| K854453 | P.E.Z. AGAR (PHENYLETHANOL AGAR) | JSJ | 1985-11-18 | 13 |
| K854452 | MANNITOL SALT AGAR | JSI | 1985-11-18 | 13 |
| K854451 | MUELLER HINTON MEDIUM | JTZ | 1985-11-18 | 13 |
| K854450 | BILE ESCULIN AZIDE AGAR | JSI | 1985-11-18 | 13 |
| K854449 | HEKTOEN ENTERIC AGAR | JSI | 1985-11-18 | 13 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named R. Kent Richards, 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 R. Kent Richards, Inc.?
FDA lists 12 510(k) clearances under the applicant name “R. Kent Richards, Inc.” (first 1985, latest 1987), across 7 product codes 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 R. Kent Richards, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name R. Kent Richards, Inc. is 13 days.
Which FDA product codes appear under R. Kent Richards, Inc.?
The most frequent FDA product codes under this applicant name are JSI (Culture Media, Selective And Differential, 3); JSJ (Culture Media, Selective And Non-Differential, 3); KZI (Culture Media, Enriched, 2).
Next steps
- See all 12 R. Kent Richards, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JSI, R. Kent Richards, 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.