Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
CAL · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
21 daysmedian FDA review time
172 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K951194 | FI-10M | Pentax Precision Instrument Corp. | 1995-04-06 | 21 | 0 |
| K951195 | FI-10P | Pentax Precision Instrument Corp. | 1995-04-06 | 21 | 0 |
| K872895 | HAEMONETICS CELL SAVER MINI SAVER AUTO. BLOOD SYS. | Haemonetics Corp. | 1988-01-11 | 172 | 0 |
| K852994 | REICHERT FLEXIBLE LARYNGOSCOPE, MODEL LS-11 | Reichert-Jung, Inc. | 1985-07-29 | 14 | 0 |
| K850978 | OLYMPUS LF-1 INTUBATION SCOPE | Olympus Corp. | 1985-05-23 | 76 | 0 |
| K802331 | AO FLEXIBLE LARYNGOSCOPE, #LS-7 | American Optical Corp. | 1980-10-10 | 17 | 0 |
| K801364 | AO STYLET LARYNGOSCOPE MODEL SLS | American Optical Corp. | 1980-06-17 | 7 | 0 |
| K791634 | AO STYLET LARYNGOSCOPE, MODEL SLS-1 | American Optical Corp. | 1979-09-17 | 27 | 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