Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
O.R. Solutions, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
51 daysmedian FDA review time
196 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K051979 | ORS MODEL 6000 ENDOSCOPE HOLDER | O.R. Solutions, Inc. | 2005-08-30 | 40 | 0 |
| K023282 | ORS-3000LD | O.R. Solutions, Inc. | 2002-11-13 | 43 | 1 |
| K023283 | 1075LD HUSH-SLUSH | O.R. Solutions, Inc. | 2002-11-13 | 43 | 0 |
| K021288 | ORS-1000LD | O.R. Solutions, Inc. | 2002-06-27 | 65 | 1 |
| K021289 | WARMER 2000LD | O.R. Solutions, Inc. | 2002-06-26 | 64 | 0 |
| K960836 | DMS-9000 | O.R. Solutions, Inc. | 1996-09-12 | 196 | 0 |
| K953654 | ORS-111 | O.R. Solutions, Inc. | 1995-09-22 | 51 | 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