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

INK — Predicate Candidate Screening

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

83 daysmedian FDA review time

126 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K152056	Winco Model S550 Stretchair	Winco Manufacturing, LLC	2016-04-11	262	0
K140095	PRIME ZOOM STRETCHER	Stryker Corporation	2014-05-20	126	0
K112502	PROCEDURAL STRECHER WITH INTELLIDRIVE P8000	Hill-Rom Co.	2011-09-19	20	0
K110671	WINCO STRETCHAIR	Winco Mfg., LLC	2011-04-22	44	0
K102236	HOVERTRANS TRANSFORMER WITH POWER DRIVE MODEL HTT-650P	D.T. Davis Enterprises Ltd. T/A Hovertech Int'L	2010-11-18	101	0
K091043	POWER DRIVE CHAIR, MODEL: TMM6	Transmotion Medical, Inc.	2009-05-11	28	0
K051861	THE SAVION INDUSTRIES MEDI-CRUISER MODEL MS777	Savion Industries, Ltd.	2005-09-28	83	0
K041924	HAUSTED POWERTRAN SERIES STRETCHER	STERIS Corporation	2004-09-09	55	0
K022309	STRYKER POWERED WHEELED STRETCHER	Stryker Corp.	2002-11-08	115	6
K912175	ISOTECHNOLOGIES LIFTSTATION & LIFTWORKS SOFTWARE	Isotechnologies, Inc.	1991-06-07	22	0
K844711	MODELS 134, 135 & 136 TRANSFER CART/TABLE	Tri W-G, Inc.	1985-03-05	92	0
K771018	TRANS 2000	Hamilton Industries, Inc.	1977-07-14	38	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