Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rinn Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
59 daysmedian FDA review time
106 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K932134 | RINN UNIVERSAL COLLIMATOR | Rinn Corp. | 1993-07-26 | 84 | 0 |
| K913885 | RINN E-Z CAPPER | Rinn Corp. | 1991-12-13 | 106 | 0 |
| K828605 | BEAM LIMITING DEVICE | Rinn Corp. | 1983-01-03 | 35 | 0 |
| K813378 | UNI-BITE DENTAL X-RAY FILM HOLDER | Rinn Corp. | 1982-01-29 | 59 | 0 |
| K772313 | X-RAY CO-ORDINATOR | Rinn Corp. | 1978-01-30 | 49 | 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