Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JRM · Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
68 daysmedian FDA review time
151 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K921568 | ORS-100 | Mnlase, Inc. | 1992-06-09 | 68 | 0 |
| K921569 | ORS-200 | Mnlase, Inc. | 1992-06-09 | 68 | 0 |
| K921570 | ORS-300 | Mnlase, Inc. | 1992-06-09 | 68 | 0 |
| K915427 | ORS-1000 | Mnlase, Inc. | 1992-01-07 | 36 | 0 |
| K913777 | SELF-CONTAINED SURGICAL SLUSH FREEZER | Taylor Corp. | 1991-09-25 | 42 | 0 |
| K894006 | SANISERV SURGICAL SLUSH SYSTEM | Saniserv, Inc. | 1989-11-03 | 151 | 0 |
| K782077 | LANCER ICE CUBE | Sherwood Medical Industries | 1979-04-03 | 111 | 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