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

JEA — Predicate Candidate Screening

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

39 daysmedian FDA review time

229 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K953071	STRYKER COMMAND2 OFFICE CONSOLE	Stryker Instruments	1995-08-08	39	0
K924094	MEND APC	Mend Technologies, Inc.	1993-03-30	229	0
K910736	JACKSON MULTIPURPOSE OPERATING TABLE	Orthopedic Systems, Inc.	1991-05-21	89	1
K911522	ARTHROBOT(TM) WRIST HOLDER ACCESSORY	Andronic Devices, Ltd.	1991-04-29	25	0
K900290	SKYTRON MODEL 1100 AND MODEL 142	Skytron, Div. the Kmw Group, Inc.	1990-02-20	29	0
K894789	DMI 250 SERIES POWER SURGERY TABLE	M.D. Intl., Inc.	1989-08-29	32	0
K881060	OSI RIZZOLI TRAUMA TABLE (ELECTRIC VERSION)	Orthopedic Systems, Inc.	1988-03-25	21	0
K874762	ARTHROTRACT UPPER LIMB TRACTION ACCESSORY	Andronic Devices, Ltd.	1987-12-10	21	0
K873080	ARTHROBOT 101 UPPER LIMB TRACTION ACCESSORY	Andronic Devices, Ltd.	1987-11-25	112	0
K873079	ARTHROBOT 100 UPPER LIMB POSITIONER	Andronic Devices, Ltd.	1987-11-25	112	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