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

DRW — Predicate Candidate Screening

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

168 daysmedian FDA review time

587 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K033513	EASI ECG ALGORITHM	Philips Medical Systems	2004-01-15	70
K020456	EASI 12 LEAD ALGORITHM	Philips Medical Systems	2002-07-09	148
K930786	EPCOR	Siemens Medical Solutions USA, Inc.	1994-09-26	587
K872781	EASI LEAD SYSTEM CABLE ASSEMBLY	Totemite Medical Electronics	1987-12-29	168
K861981	ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR	Vital Signs, Inc.	1986-08-25	95
K851632	PCX-100 PATIENT INPUT LEADWIRE	Eaton Medical Group	1985-11-08	204
K851627	KBX-20 OUTBOARD KEYBOARD ACCESS. FOR G-2000 ELECTR	Eaton Medical Group	1985-11-08	204
K761210	LIMB LEAD SEL. (ECG LEAD SWITCHING AD.)	Physio-Control Corp.	1976-12-21	14

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