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

E & M Engineering, Inc. — Predicate Candidate Screening

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

175 daysmedian FDA review time

472 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K984276	DISPOSABLE ELECTROSURGERY GROUNDING PAD	E & M Engineering, Inc.	1999-02-10	72	0
K952030	LOOP/SQUARE ELECTRODE	E & M Engineering, Inc.	1996-07-31	457	0
K945531	BLADE ELECTRODE	E & M Engineering, Inc.	1995-02-10	88	0
K936304	ELECTROSURGICAL PENCIL	E & M Engineering, Inc.	1994-06-13	175	2
K936075	REUSABLE, HAND CONTROLLED ESP	E & M Engineering, Inc.	1994-06-06	168	0
K921271	ELECTROSURGICAL UNIT	E & M Engineering, Inc.	1993-07-02	472	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