Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

FQZ — Predicate Candidate Screening

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

62 daysmedian FDA review time

247 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K110305	CRY-ACTRACKERCAM	Brymill Cryogenic Cystems	2012-01-13	345
K963049	STERI-AID KIT	Steri-Aid, Inc.	1996-11-12	110
K946046	DEROYAL TECHNOLOGICES, INC. LIQUID CRYSTAL SKIN TEMPERATURE	Deroyal Critical Care, Div. Deroyal Technologies	1995-07-19	219
K894893	POINT CHECKER COLOR STRIP THERMOMETER	Kyowa Medex Co., Ltd.	1990-04-05	247
K884612	FRANKLIN COLLECTOR(R)	Franklin Diagnostics, Inc.	1989-03-27	143
K881286	TEMPA-DOT CLINICAL THERMOMETER SHEATH	Pymah Corp.	1988-06-08	75
K863181	HEALTHCHECK THERM-STRIP	Healthcheck Corp.	1986-09-11	23
K853515	PEE WEE THERMOMETERS	Joel R.L. Ehren Kranz	1985-10-16	55
K822423	BABY TEMP PACIFIER	Trp Energy Sensors, Inc.	1982-10-13	62
K791574	MODIFIED TEMPA-DOT THERMOMETER	Info-Chem	1979-09-12	30
K790890	TEMPO2-I DISPOSABLE THERMOMETERS	Airlife, Inc.	1979-06-27	51
K772233	THERMOMETER RECAL ADAPTER	Info-Chem	1977-12-20	13
K771038	THERMOMETER, SINGLE USE, STRIP, TEMPADOT	Organon, Inc.	1977-06-27	17
K771037	THERMOMETER, SINGLE USE, STRIP, TEMPADOT	Info-Chem	1977-06-27	17

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