Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HQO — Predicate Candidate Screening
12 FDA 510(k) clearances under this product code; the 50 most recent screened below.
83 daysmedian FDA review time
99 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K070871 | STARION UNIVERSAL POWER SUPPLY | Starion Instruments | 2007-04-13 | 15 | 0 |
| K043155 | STARION UNIVERSAL POWER SUPPLY (UPS) | Starion Instruments | 2004-12-09 | 24 | 0 |
| K002341 | THERMAL CAUTERY UNIT, MODEL 150 | Geiger Medical Technologies, Inc. | 2000-10-23 | 83 | 0 |
| K000893 | AC POWERED THERMAL CAUTERY UNIT | Starion Instruments | 2000-06-14 | 86 | 0 |
| K971538 | MENTOR GEMINI HEMOSTATIC ERASER | Mentor Ophthalmics, Inc. | 1997-07-14 | 77 | 0 |
| K962135 | D.O.R.C. MICRODIATHERMY SYSTEM | Dutch Ophthalmic USA, Inc. | 1996-08-29 | 87 | 0 |
| K943031 | BIPOLAR ELECTROSURGICAL PENCIL | Boston Surgical Products, Inc. | 1994-09-23 | 88 | 0 |
| K900913 | ADLER DISPOSABLE BIPOLAR CORD | Adler Instrument Co. | 1990-04-04 | 36 | 0 |
| K874367 | VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF | Spembly Medical , Ltd. | 1988-01-04 | 73 | 0 |
| K852075 | SITE-MALIS BIPOLAR COAGULATOR MODULE | Valley Forge Scientific Corp. | 1985-08-20 | 99 | 0 |
| K844775 | EFFNER-EYE CAUTERY WITH BATTERY HANDLE | Mecron Medical Products, Inc. | 1985-08-12 | 245 | 0 |
| K810017 | MICROSURG CAUTERY | Medical Products Development, Inc. | 1981-01-05 | 0 | 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