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

Metrika, Inc. — Predicate Candidate Screening

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

63 daysmedian FDA review time

190 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K051321	INVIEW	Metrika, Inc.	2005-06-13	24
K033847	A1CNOW FOR HOME AND PROFESSIONAL USE	Metrika, Inc.	2003-12-23	12
K022661	A1CNOW FOR HOME USE	Metrika, Inc.	2002-12-13	126
K020235	A1CNOW FOR PROFESSIONAL USE	Metrika, Inc.	2002-02-15	23
K020234	A1CNOW FOR RX HOME USE	Metrika, Inc.	2002-02-15	23
K000885	DRX HBA1C - FOR PRESCRIPTION HOME USE	Metrika, Inc.	2000-09-26	190
K000887	DRX HBA1C	Metrika, Inc.	2000-07-26	128
K992997	OSTEOMARK NTX POC	Metrika, Inc.	1999-11-09	63
K991532	DRX QT. HCG	Metrika, Inc.	1999-09-17	137
K984530	DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE	Metrika, Inc.	1999-08-10	232
K991917	OSTEOMARK NTX POINT OF CARE (POC) CONTROL SET	Metrika, Inc.	1999-07-12	35

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