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

JTQ — Predicate Candidate Screening

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

34 daysmedian FDA review time

56 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K875275	WINTHROP PHARMACEUTICALS CONTRAST MEDIA WARMER	Sterling Drug, Inc.	1988-01-27	34
K853379	PLATE INCUBATOR	Scientific Sales Intl., Inc.	1985-09-03	22
K831592	ANHYDRIC INCUBATORS, CULTURE INCUBATOR	Boekel Industries, Inc.	1983-06-16	30
K830322	C.A.T. REAGENT KIT	Remel Co.	1983-03-28	56
K830227	AUTOMATED ELISA READER LBI 300	Bionetic Laboratory Products	1983-03-10	45
K830405	LBI-100 37DEGREES INCUBATOR	Bionetic Laboratory Products	1983-03-10	31
K822564	WATER BATH	Boekel Industries, Inc.	1982-09-14	21
K812826	FORMA CH/P GAS PROCESSOR	Forma Scientific, Inc.	1981-10-23	15
K812340	TITERTEK MICROPLATE INCUBATOR	Flow Laboratories, Inc.	1981-09-23	36
K801462	SPOR-O-THERM	Mdt Corp., Inc.	1980-07-28	34
K792060	TEMPTRONIC 100 WATER BATH	Sybron Corp.	1979-12-04	50
K760928	BLOOD BANK DRI-BATH	Thermolyne Corp.	1977-01-10	73

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