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

FSA — Predicate Candidate Screening

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

40 daysmedian FDA review time

183 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K942807	SURGICAL LIFT SHEET	Surgin Surgical Instrumentation, Inc.	1994-08-02	49
K930625	SANITAS PATIENT LIFT	Dutton-Lainson Co.	1993-09-13	217
K902141	ANOLIFT - PORTABLE & ANOLIFT - GANTRY	Anodyne Corp.	1990-09-12	120
K860837	HOYER ONE-TOUCH POWER LIFTER	Ted Hoyer & Co., Inc.	1986-03-27	22
K851844	MOLIFT	Madshus A/S	1985-05-17	21
K844976	MEDI-MAN WATER POWERED BATH LIFT & HYDRAULIC LIFT	Medi-Man Rehabilitation Products, Inc.	1985-04-01	96
K841395	SHOWER TROLLEY	Setma, Inc.	1984-05-07	34
K841398	VARIABLE HEIGHT TRANSFER CHAIR	Setma, Inc.	1984-05-07	34
K840997	BATTERY POWERED PATIENT LIFT	Invacare Corp.	1984-04-17	40
K823206	MARTIN PELVIC LIFT	Martin Pelvic Lift Co.	1983-04-28	183
K811899	CENTURY LIFT TRANSFER SYSTEM	Century Manufacturing Co.	1981-07-23	22
K792601	LIFELIFT MODELS ONE AND TWO	Corda Int'L Holiday, Inc.	1979-12-31	13
K780684	PATIENT LIFT	Orthopedic Equipment Co., Inc.	1978-06-06	43

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