Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

HQP — Predicate Candidate Screening

24 FDA 510(k) clearances under this product code; the 50 most recent screened below.

90 daysmedian FDA review time

244 days90th percentile

24clearances measured

K-number	Device	Applicant	Decided	Review days
K121441	CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED	Bovie Medical Corporation	2012-07-20	66
K083428	F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BA	Fiab Spa	2009-09-01	286
K062659	KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SER	Kirwan Surgical Products, Inc.	2007-03-09	183
K023506	SURGICAL MEDICAL DEVICE CAUTERY	Modern Medical Equipment Mfg., Ltd.	2004-01-13	452
K002547	STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR	Starion Instruments	2000-10-20	64
K994019	CAUTERY GRASPER/DISSECTOR	Starion Instruments	2000-01-20	55
K990728	THERMAL CAUTERY DEVICE, FORCEPS	Starion Instruments	1999-06-03	90
K952784	OXBORO-MEDICAL CAUTERY TIP CLEANER	Oxboro Medical Intl., Inc.	1995-07-13	24
K945761	LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE, REPLACEABLE TI	Aaron Medical Industries	1995-04-10	152
K945762	LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE	Aaron Medical Industries	1995-02-07	90
K945763	LOW TEMPERATURE CAUTERY ELONGATED FINE TIP	Aaron Medical Industries	1995-02-07	90
K945493	OPHTHALMIC CAUTERY	Aaron Medical Industries	1995-01-30	90
K933079	ELECTROCAUTERY SYSTEM MODEL 1980	Pmt Corp.	1994-02-22	244
K875260	EFFNER CAUTERY INSTRUMENTS	Effner and Spreine Co.	1988-06-06	167
K841325	REPLACE-A-TIP RECHARG. LOW TEMP.	Suncoast Medical Manufacturers, Inc.	1984-05-09	37
K841326	REPLACE-A-TIP RECHARGEABLE HIGH TEMP	Suncoast Medical Manufacturers, Inc.	1984-05-09	37
K840425	OPTHERM FINE TIP	Suncoast Medical Manufacturers, Inc.	1984-05-09	99
K840426	OPTHERM EXTRA FINE TIP	Suncoast Medical Manufacturers, Inc.	1984-05-09	99
K820157	XOMED THERMAL MYRINGOTOMY SYSTEM	Xomed, Inc.	1982-03-02	42
K810013	MULTIPERFECTEMP CAUTERY	Medical Products Development, Inc.	1981-04-23	108
K810016	REPLACABLE BATTERY PERFECTEMP CAUTERY	Medical Products Development, Inc.	1981-04-23	108
K810012	MULTIMICRO SURGICAL CAUTERY	Medical Products Development, Inc.	1981-04-23	108
K801078	PERFECTEMP OPHTHALMIC CAUTERY	Medical Products Development, Inc.	1980-06-04	28
K771189	HOT TEMP CAUTERY	Edward Weck, Inc.	1977-07-11	10

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