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

JQT — Predicate Candidate Screening

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

35 daysmedian FDA review time

177 days90th percentile

18clearances measured

K-number	Device	Applicant	Decided	Review days
K111356	ASIMANAGER - AT	Arlington Scientific, Inc.	2011-11-09	177
K944185	ISOSCAN	Isolab, Inc.	1994-11-17	83
K915332	MODEL 795 FLUOROMETER/DENSITOMETER	Ciba Corning Diagnostics Corp.	1992-02-18	84
K885254	TARGET READER	V-Tech, Inc.	1989-01-27	35
K860645	ELECTROPHORESIS DATA CENTER (EDC)	Helena Laboratories	1986-12-17	300
K862956	ICON READER	Hybritech, Inc.	1986-08-19	14
K853734	APOLLO DENSITOMETER	Astral Medical Systems	1985-09-25	19
K851154	ELECTROPHORESIS APPARATUS, FOR CLINICAL USE 160,18	Astral Medical Systems	1985-05-13	52
K850617	CORNING 780 FLUOROMETER/DENSITOMETER	Corning Medical & Scientific	1985-03-12	25
K850260	GLEMAN ACD-2020 AUTOMATIC COMPUTING DENSITOMETER	Gelman Sciences, Inc.	1985-02-27	36
K842313	ELVI 146 SEROSCAN	Logos Scientific, Inc.	1984-09-10	90
K842056	ELVI 165 PROTEO SEROSKOP	Logos Scientific, Inc.	1984-06-22	31
K810619	710 FLUOROMETER/DENSITOMETER	Corning Medical & Scientific	1981-03-27	18
K803240	CORNING 760 FLUOROMETER/DENSITOMETER	Transidyne General Corp.	1981-01-09	17
K780901	AUTOMATED ELECTROPHORESIS SYSTEM	Olympus Corp.	1978-06-28	27
K780318	MODULAR SCANNING DENSITOMETER SYS.	Transidyne General Corp.	1978-04-12	47
K772325	DENSITOMETER 18, COMPUTING, AUTO.	Gelman Instrument Co.	1978-01-12	24
K770026	FLOUROMETER/DENSITOMETER MODEL 720	Corning Medical & Scientific	1977-01-26	20

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