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

EMG — Predicate Candidate Screening

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

57 daysmedian FDA review time

264 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days
K062130	MEISINGER BENEX, MODEL BE001	Hager& Meisinger GmbH	2007-04-16	264
K060691	EASY X-TRAC SYSTEM	A. Titan Instruments, Inc.	2006-06-12	89
K851708	500/1 TO 500/80 VARIOUS TYPES OF ENGLISH PAT DENTA	Artiberia	1985-07-01	67
K851709	560 TO 577 VARIOUS TYPES OF FORCEPS FOR CHILDREN	Artiberia	1985-06-11	47
K851712	600/203 TO 650/74XN VARIOUS TYPES OF DENT EXTRACTI	Artiberia	1985-06-11	47
K851711	600/7 TO 600/288 VARIOUS TYPES OF AMER. PATTERN DE	Artiberia	1985-06-11	47
K851105	TOOTH EXTRACTING FORCEPS 151(2010)-875 PCS. SS410/	The Huxley Instrument Corp.	1985-05-15	57
K840312	CAT. 8 DENTAL DEVICES	Imm Enterprises , Ltd.	1984-04-05	72
K823325	DENTAL INSTRUMENTS - SURGICAL FORCEPS	Miltex, Inc.	1982-11-24	16
K821781	BEACH FORCEP NO. 150 AND NO. 151	Pacific Dental Corp.	1982-07-02	15

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