Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rudolph Beaver, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
65 daysmedian FDA review time
148 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K883361 | ARTHRO-TRAC(TM) | Rudolph Beaver, Inc. | 1988-10-13 | 65 | 0 |
| K875030 | OCU-1 | Rudolph Beaver, Inc. | 1988-05-03 | 148 | 0 |
| K862709 | MECHANICAL CYSTITOME | Rudolph Beaver, Inc. | 1986-08-01 | 16 | 0 |
| K860305 | BEAVER MICRO-GEM GAUGE BLOCK | Rudolph Beaver, Inc. | 1986-02-12 | 15 | 0 |
| K852828 | BEAVER R-K KNIFE | Rudolph Beaver, Inc. | 1985-11-04 | 125 | 0 |
| K853129 | BEAVER MULTIPURPOSE SAPPHIRE KNIFE | Rudolph Beaver, Inc. | 1985-08-06 | 11 | 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