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

Starion Instruments — Predicate Candidate Screening

13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

55 daysmedian FDA review time

86 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K070871	STARION UNIVERSAL POWER SUPPLY	Starion Instruments	2007-04-13	15	0
K062257	STARION INSTRUMENTS THERMAL LITIGATING SHEARS	Starion Instruments	2006-10-10	67	2
K050308	THERMAL CAUTERY PROBE	Starion Instruments	2005-02-25	17	0
K043155	STARION UNIVERSAL POWER SUPPLY (UPS)	Starion Instruments	2004-12-09	24	0
K002547	STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR	Starion Instruments	2000-10-20	64	0
K001262	THERMAL CAUTERY FORCEPS	Starion Instruments	2000-06-14	56	0
K001273	STARION INSTRUMENTS POWER POINT CAUTERY CLAMP	Starion Instruments	2000-06-14	55	0
K000893	AC POWERED THERMAL CAUTERY UNIT	Starion Instruments	2000-06-14	86	0
K000296	STARION CAUTERY HOOK	Starion Instruments	2000-03-07	36	0
K000250	CAUTERY FORCEPS WITH FOOTSWITCH	Starion Instruments	2000-03-07	40	0
K994019	CAUTERY GRASPER/DISSECTOR	Starion Instruments	2000-01-20	55	0
K992460	CAUTERY CLAMP AND BATTERY PACK POWER SUPPLY	Starion Instruments	1999-10-05	74	0
K990728	THERMAL CAUTERY DEVICE, FORCEPS	Starion Instruments	1999-06-03	90	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