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

Valleylab — Predicate Candidate Screening

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

88 daysmedian FDA review time

129 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K092879	LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER-DIVIDER	Valleylab	2009-10-16	28	1
K063195	LIGASURE ADVANCE LAPAROSCOPIC SEALER/DIVIDER WITH DISSECTING	Valleylab	2006-11-29	40	0
K053535	VIVAWAVE MICROWAVE ABLATION SYSTEM	Valleylab	2006-04-27	129	0
K053290	COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES	Valleylab	2006-03-15	110	0
K052796	COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES	Valleylab	2006-02-03	123	0
K051644	VALLEYLAB FORCETRIAD ELECTROSURGICAL GENERATOR	Valleylab	2005-08-11	52	0
K051627	VALLEYLAB G3000 ELECTROSURGICAL INSTRUMENT	Valleylab	2005-07-22	32	0
K043273	LIGASURE VESSEL SEALING SYSTEM. LIGASURE INSTRUMENTS	Valleylab	2005-01-05	40	0
K042216	COOL-TIP RF ABLATION SYSTEM	Valleylab	2004-11-12	88	0
K041587	LIGASURE PRECISE MODEL #LS1200/LIGASURE 5MM LAPAROSCOPIC SEA	Valleylab	2004-09-28	106	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