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

Stryker Medical · Predicate Candidate Screening

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

108 daysmedian FDA review time

230 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K222818	Xpedition ™ Powered Stair Chair (625700000000)	Stryker Medical	2023-01-24	127	0
K180834	Altrix Precision Temperature Management System	Stryker Medical	2018-08-10	133	0
K171149	Altrix Temperature Management Wraps	Stryker Medical	2017-07-18	90	0
K152266	Altrix Precision Temperature Management System	Stryker Medical	2016-12-02	479	0
K113598	POWER-LOAD COT FASTENER SYSTEM	Stryker Medical	2011-12-20	15	3
K946149	STRYKER AGILITY INTENSIVE CARE BED	Stryker Medical	1995-03-14	88	0
K943864	STRYKER 8000 SURGERY STRETCHER	Stryker Medical	1994-08-25	17	0
K935949	STRYKER 5000	Stryker Medical	1994-06-17	186	0
K941738	STRYKER 5050 STRECHAIR	Stryker Medical	1994-05-06	29	0
K940068	STRYKER OPERATING ROOM TABLE	Stryker Medical	1994-05-05	119	0
K935297	STRYKER AMBULANCE COT MODEL 6060	Stryker Medical	1994-02-18	108	0
K920526	STRYKER DYNAMIC MATTRESS SYSTEM (DMS) MODEL #2500	Stryker Medical	1992-09-21	230	0
K920704	STRYKER I.V. CADDY ACCESSORY DEVICE	Stryker Medical	1992-03-23	34	0
K912237	STRYKER ECLIPSE WARMING STRETCHER	Stryker Medical	1991-07-30	70	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