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

Jerome Medical · Predicate Candidate Screening

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

63 daysmedian FDA review time

1065 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K051918	RESOLVE OPEN BACK HALO RINGS	Jerome Medical	2005-08-17	33	3
K930021	J TONGS	Jerome Medical	1995-12-06	1065	0
K930153	SYSTEM III HALO RING	Jerome Medical	1993-08-06	206	0
K882877	JMS CERVICAL TRACTION DEVICE/HALO DEVICE	Jerome Medical	1988-09-30	81	0
K870053	TORQUEDRIVER WRENCH	Jerome Medical	1987-03-11	63	0
K864969	JMS HALO APPLICATION TRAY	Jerome Medical	1987-02-18	58	0
K844490	TRACTION ACCESSORIES	Jerome Medical	1985-02-21	93	0
K822780	CERVICAL BRACE	Jerome Medical	1982-10-06	22	0
K821582	WARM'N FORM SPORTS SUPPORTS	Jerome Medical	1982-06-10	13	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