Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
EQL · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
72 daysmedian FDA review time
86 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K984521 | RIWO DRIVE SYSTEM 2302 WITH GENERATOR, SMALL MOTOR HANDLES, | Richard Wolf Medical Instruments Corp. | 1999-03-17 | 86 | 0 |
| K921184 | RLS 9100 RHINO-LARYNGEAL STROBOSCOPE | Kay Elemetrics Corp. | 1992-05-28 | 80 | 0 |
| K921285 | 9105 RIGID TELESCOPIC ENDOSCOPE | Kay Elemetrics Corp. | 1992-05-28 | 72 | 0 |
| K884933 | ENDOSTROBOSCOPE IV | Jedmed Instrument Co. | 1989-02-15 | 79 | 0 |
| K842090 | RHINO-LARYNX STROBOSCOPE TYPE 4914 | Bruel & Kjaer Industri A/S | 1984-07-18 | 55 | 0 |
| K822523 | LARYNGOSTROBOSCOPE | Kelleher Corp. | 1982-09-09 | 17 | 0 |
| K801866 | PENTAX LARYNGO-STROBOSCOPE MODEL LS-1A | Pentax Precision Instrument Corp. | 1980-09-16 | 42 | 0 |
| K770466 | STOCKINGS, RVS TM | Parke-Davis Co. | 1977-03-28 | 18 | 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