Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Rapid City Regional Hospital, Inc. · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
31 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K850724 | CULTURE MEDIA NONSELECTIVE & NONDIFFERENTIAL | Rapid City Regional Hospital, Inc. | 1985-03-25 | 31 | 0 |
| K850715 | MUELLER HINTON AGAR | Rapid City Regional Hospital, Inc. | 1985-03-22 | 28 | 0 |
| K850716 | SELENITE F BROTH | Rapid City Regional Hospital, Inc. | 1985-03-22 | 28 | 0 |
| K850717 | AMIES TRANSPORT MEDIA | Rapid City Regional Hospital, Inc. | 1985-03-22 | 28 | 0 |
| K850719 | DNASE TEST MEDIA, CHRISTENSEN'S UREA AGAR | Rapid City Regional Hospital, Inc. | 1985-03-22 | 28 | 0 |
| K850720 | EOSIN METHYLENE BLUE AGAR, SS AGAR, XLD AGAR 6.5% | Rapid City Regional Hospital, Inc. | 1985-03-22 | 28 | 0 |
| K850721 | KLIGER'S IRON AGAR, SIM MEDIA, MRVP MEDIUM, BILE E | Rapid City Regional Hospital, Inc. | 1985-03-22 | 28 | 0 |
| K850722 | MARTIN LEWIS AGAR | Rapid City Regional Hospital, Inc. | 1985-03-22 | 28 | 0 |
| K850723 | SABOURAUD'S DEXTROSE AGAR, BORDET GENGOU AGAR, MYC | Rapid City Regional Hospital, Inc. | 1985-03-22 | 28 | 0 |
| K850718 | CORN MEAL AGAR | Rapid City Regional Hospital, Inc. | 1985-03-20 | 26 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda