Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

HQR — Predicate Candidate Screening

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

116 daysmedian FDA review time

233 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K050308	THERMAL CAUTERY PROBE	Starion Instruments	2005-02-25	17	0
K990064	DI-RHEX OPHTHALMIC DIATHERMY SYSTEM	Ophthalmic Technologies, Inc.	1999-04-04	86	0
K980522	REFRACTEC MCS-100	Refractec, Inc.	1998-07-22	162	0
K972749	PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P	C.M. Chance , Ltd.	1998-03-13	233	0
K952151	STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201,	Storz	1996-03-04	301	0
K955158	SURGITRON	Ellman Intl., Inc.	1996-02-09	88	0
K952569	GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR	Gamp & Assoc.	1996-01-05	214	0
K941495	RETURN PATH DIATHERMY HANDLE	Mira, Inc.	1994-07-15	109	0
K934320	MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GA	Mentor O & O, Inc.	1994-02-16	166	1
K895800	ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATOR	Advanced Surgical Products, Inc.	1990-01-22	116	0
K870194	UNITED SURGICAL CORP. DIATHERMIC PLUS	United Surgical Corp.	1987-02-20	31	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