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

Chronimed, Inc. — Predicate Candidate Screening

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

163 daysmedian FDA review time

217 days90th percentile

5clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K010039	QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER,	Chronimed, Inc.	2001-08-10	217	0
K983432	SUPREME II CONTROL SOLUTIONS	Chronimed, Inc.	1998-12-17	79	0
K980573	SENSOREX BLOOD GLUCOSE MONITORING SYSTEM	Chronimed, Inc.	1998-07-30	163	0
K981555	DIASCREEN REAGENT STRIPS	Chronimed, Inc.	1998-06-01	31	1
K963544	SUPREME II METER	Chronimed, Inc.	1997-02-20	169	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