Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

LBK · Predicate Candidate Screening

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

79 daysmedian FDA review time

322 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K972612	DISSECTRON PORTABLE UNIT	Satelec	1997-10-08	86
K962952	OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU)	Olympus Optical, Co.	1996-11-29	122
K884412	CUSA SYSTEM 200C,T & M ULTRASONIC SURGICAL ASPIRA.	Valleylab, Inc.	1988-12-02	43
K884413	CUSA SYSTEM 200H ULTRASONIC SURGICAL ASPIRATOR	Valleylab, Inc.	1988-12-02	43
K883522	AMERIMED ULTRASONIC SURGICAL ASPIRATION KIT	Amerimed US Corp.	1988-09-30	44
K855138	BOVIE ULTRASONIC SURGICAL SYSTEM	Clinical Technology Corp.	1986-11-10	322
K853143	COOPER LASER SONICS CUSA MODEL 200	Cooper Lasersonics, Inc.	1985-10-16	79

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