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

Dan Med, Inc. — Predicate Candidate Screening

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

190 daysmedian FDA review time

274 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K013210	TRUWAVE	Dan Med, Inc.	2002-04-04	190	0
K012885	NEUROMOVE NM900	Dan Med, Inc.	2001-11-08	72	0
K010745	EMS 3000	Dan Med, Inc.	2001-06-27	106	0
K991241	IF8000	Dan Med, Inc.	1999-11-02	204	1
K972997	AM800 AUTOMOVE EMG TRIGGERED ELECTRICAL MUSCLE STIMULATION	Dan Med, Inc.	1997-11-10	90	0
K964738	ELPHA 2000 CONTI	Dan Med, Inc.	1997-08-14	274	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