Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Circon Corp. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
273 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K992544 | TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM | Circon Corp. | 1999-10-26 | 88 | 0 |
| K992126 | CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM | Circon Corp. | 1999-08-03 | 41 | 0 |
| K981611 | SNAP-N-PEEL INTRODUCERS | Circon Corp. | 1998-07-30 | 85 | 0 |
| K980972 | RIGID CULDOSCOPE AND ACCESSORIES | Circon Corp. | 1998-06-12 | 88 | 0 |
| K973820 | USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPOR | Circon Corp. | 1998-05-12 | 217 | 0 |
| K964594 | VAPORTRODE VAPORIZATION ELECTRODE -GROOVED/FLUTED/SPIKED(GVE | Circon Corp. | 1997-08-15 | 273 | 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