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

LGX — Predicate Candidate Screening

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

35 daysmedian FDA review time

119 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K945163	ECHOCARDIOGRAPHY	Tri W-G, Inc.	1995-02-17	119
K894134	POWER EXAMINATION TABLE MODEL # 411	Midmark Corp.	1989-08-28	76
K894144	POWER EXAMINATION TABLE MODEL # 405	Midmark Corp.	1989-08-28	76
K883680	MEDALIST EXAMINATION TABLE	Hamilton Industries, Inc.	1988-10-04	36
K882010	POWER EXAMINATION TABLE	Enochs Mfg., Inc.	1988-07-13	61
K864072	ADEC 1005-C CHAIR	Cherne Industries, Inc.	1986-11-07	18
K860519	RELIANCE MODEL 200 PODIATRY CHAIR	F. & F. Koenigkramer	1986-02-19	8
K845023	STORZ PLASTIC SURGERY & EXAMINATION LOUNGE 7000	Storz Instrument Co.	1985-01-28	32
K830294	MEDICAL EXAM TABLE	Coe Laboratories, Inc.	1984-01-11	349
K832768	S & W SW52E W/POWER BACK LIFT	S & W Enterprises, Inc.	1983-09-20	35
K820823	MULTIPLE, MODEL #17	Midmark Corp.	1982-04-21	28
K811623	SMR PARAGON CHAIR TABLE	Smr	1981-07-02	23
K811190	THREE MODELS OF TABLES, STOOLS, & LIGHTS	Midmark Corp.	1981-05-08	9
K810900	CASTLE PROCEDURE AND RITTER EXAM. TABLES	Sybron Corp.	1981-04-21	18

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