Rapid City Regional Hospital, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Rapid City Regional Hospital, Inc.” (first 1985, latest 1985), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 28 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 |
|---|---|---|---|
| JSH | Culture Media, Non-Selective And Differential | 3 | 3 |
| JSI | Culture Media, Selective And Differential | 2 | 2 |
| JSJ | Culture Media, 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 |
| KZI | Culture Media, Enriched | 1 | 1 |
Review panels
- Microbiology (10)
Most recent Rapid City Regional Hospital, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K850724 | CULTURE MEDIA NONSELECTIVE & NONDIFFERENTIAL | KZI | 1985-03-25 | 31 |
| K850723 | SABOURAUD'S DEXTROSE AGAR, BORDET GENGOU AGAR, MYC | JSI | 1985-03-22 | 28 |
| K850722 | MARTIN LEWIS AGAR | JTY | 1985-03-22 | 28 |
| K850721 | KLIGER'S IRON AGAR, SIM MEDIA, MRVP MEDIUM, BILE E | JSH | 1985-03-22 | 28 |
| K850720 | EOSIN METHYLENE BLUE AGAR, SS AGAR, XLD AGAR 6.5% | JSI | 1985-03-22 | 28 |
| K850719 | DNASE TEST MEDIA, CHRISTENSEN'S UREA AGAR | JSH | 1985-03-22 | 28 |
| K850717 | AMIES TRANSPORT MEDIA | JSM | 1985-03-22 | 28 |
| K850716 | SELENITE F BROTH | JSJ | 1985-03-22 | 28 |
| K850715 | MUELLER HINTON AGAR | JTZ | 1985-03-22 | 28 |
| K850718 | CORN MEAL AGAR | JSH | 1985-03-20 | 26 |
Recalls
openFDA lists no recalls under a recalling firm named Rapid City Regional Hospital, 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.
- Rapid Medical Ltd. (7 510(k)s)
- Rapid Biomedical GmbH (7 510(k)s)
- Rapid Diagnostic Laboratories, Inc. (6 510(k)s)
- Rapid Diagnostics, Inc. (4 510(k)s)
- Rapid Aid Corp. (3 510(k)s)
- Rapid Pathogen Screening, Inc. (3 510(k)s)
- Rapid Injection Systems Corp. (2 510(k)s)
- Rapid Reboot Recovery Products, LLC (2 510(k)s)
- Rapid Machine & Tool Corp. (1 510(k)s)
- Rapid Mfg. Co. (1 510(k)s)
- Rapid Nexus Nanotech Wound Solutions, Inc. (1 510(k)s)
- Rapid Response Solutions, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Rapid City Regional Hospital, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Rapid City Regional Hospital, Inc.” (first 1985, latest 1985), 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 Rapid City Regional Hospital, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Rapid City Regional Hospital, Inc. is 28 days.
Which FDA product codes appear under Rapid City Regional Hospital, Inc.?
The most frequent FDA product codes under this applicant name are JSH (Culture Media, Non-Selective And Differential, 3); JSI (Culture Media, Selective And Differential, 2); JSJ (Culture Media, Selective And Non-Differential, 1).
Next steps
- See all 10 Rapid City Regional Hospital, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JSH, Rapid City Regional Hospital, 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.