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

Emerge Medical · Predicate Candidate Screening

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

71 daysmedian FDA review time

133 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days
K141347	EMERGE MEDICAL IM NAIL SYSTEM	Emerge Medical	2014-10-02	133
K140107	EMERGE MEDICAL DISTAL RADIUS SET	Emerge Medical	2014-03-13	57
K140119	EMERGE MEDICAL PERIARTICULAR AND LOCKING LARGE FRAGMENT SYST	Emerge Medical	2014-03-12	55
K140098	EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM	Emerge Medical	2014-03-12	57
K133536	EMERGE MEDICAL BONE PLATE SYSTEM	Emerge Medical	2014-02-26	100
K133541	EMERGE MEDICAL SMALL AND LARGE NON-LOCKING FRAGMENT PLATE SY	Emerge Medical	2014-01-28	71
K133452	EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM	Emerge Medical	2014-01-08	57
K131480	EMERGE MEDICAL LOCKING ONE-THIRD TUBULAR PLATE SYSTEM	Emerge Medical	2013-07-03	42
K122489	EMERGE MEDICAL SOLID BONE SCREWS	Emerge Medical	2012-12-10	117
K102343	EMERGE MEDICAL CANNULATED SCREW FIXATION SYSTEM	Emerge Medical	2010-11-23	98

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