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

LIB · Predicate Candidate Screening

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

35 daysmedian FDA review time

89 days90th percentile

43clearances measured

K-number	Device	Applicant	Decided	Review days
K023677	OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV)	Osmetech	2003-01-29	89
K920416	SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMB	Behring Diagnostics, Inc.	1992-04-08	68
K912558	GULL ELISAWARE	Gull Laboratories, Inc.	1991-09-16	97
K872273	CORNING EASY WASH ELISA PLATES	Corning Medical & Scientific	1987-07-07	22
K871559	CELL LIFTER	Corning Costar Corp.	1987-05-15	23
K864249	NORMAL SALINE STERILE	Mds Laboratories, Inc.	1987-03-31	154
K863789	CORNING ELISA PLATES	Corning Medical & Scientific	1986-10-03	7
K862112	MICROSCOPE SLIDES	Abco Dealers, Inc.	1986-06-13	10
K854604	AUTO MASH	Dynatech Corp.	1985-12-06	18
K854603	MULTI MASH 2000	Dynatech Corp.	1985-12-06	18
K854602	MINI MASH 2000	Dynatech Corp.	1985-12-06	18
K854423	IMMULON 1 EIA TUBES, IMMULON 2 EIA TUBES	Dynatech Laboratories, Inc.	1985-11-20	15
K853285	MYWASHER 5	Scientific Sales Intl., Inc.	1985-10-04	60
K853745	MIC-CONCEPT VIEWBOX	Microtech Medical Systems, Inc.	1985-09-19	10
K850725	QUADRA TITER MICRO PLATES	Microtech Medical Systems, Inc.	1985-04-30	67
K844476	PORTABLE DIAGNOSTIC LABORATORY	Portable Medical Laboratories, Inc.	1985-03-13	114
K844442	RAPID DIAGNOSTIC KIT	Portable Medical Laboratories, Inc.	1985-02-01	77
K844473	HAND-HELD SLIDE READER	Portable Medical Laboratories, Inc.	1985-01-04	46
K843483	PHARMA-PLAST PETRI DISH	Zimmar Consulting , Ltd.	1984-09-21	15
K842052	GIARDIA GUARD	Gelman Sciences, Inc.	1984-09-11	112
K842057	MACLEAN-FOGG, DISPOS-INOCULA-LOOPS	Polymer Technology Corp.	1984-06-07	16
K841632	CODE-A-WELL SERIES 200 PLATE	Plastic Injectors, Inc.	1984-05-25	35
K841937	CODE-A-WELL SERIES 300 PLATE	Plastic Injectors, Inc.	1984-05-22	11
K841390	CODE-A-WELL	Plastic Injectors, Inc.	1984-05-02	29
K833131	HCC-MYCOBACTERIA STAIN KIT	Dr. C.V. Jacob	1983-10-27	44
K831641	READER MICROELISA SYSTEM	Organon Teknika Corp.	1983-08-11	80
K832117	IMMULON SUBSTRATE REMOVAWELL STRIPS	Dynatech Corp.	1983-08-08	39
K831658	MICROELISA COMP	Organon Teknika Corp.	1983-07-26	64
K831642	HEATING BLOCK MICROELISA SYSTEM	Organon Teknika Corp.	1983-07-26	64
K831643	STRIPREADER MICROELISA SYSTEM	Organon Teknika Corp.	1983-07-26	64
K831448	SPIA SYS FOR SOLID PHASE IMMUNOASSAYS	R&D Systems, Inc.	1983-06-08	34
K831450	DISPOSABLE STERILE FILTER SYSTEM	Corning Medical & Scientific	1983-06-02	28
K823787	HANDI-WASH	Dynatech Corp.	1983-03-09	83
K823833	MICRO STIX #011-010-5000 & HOLDER#5100	Dynatech Corp.	1983-03-08	77
K823557	REMOVAWELL PLATE LID	Dynatech Corp.	1982-12-28	26
K822960	MICROFLUOR B PLATE & MICRO FLUOR W PLATE	Dynatech Corp.	1982-11-16	42
K822962	MICROFLUOR B REMOVAWELL STRIPS	Dynatech Corp.	1982-11-16	42
K822292	DISPOSABLE DISPENSING-SPREAD PIPETS	American Dade	1982-08-25	23
K820346	CALI-PIPETTE	Carr-Scarborough Microbiologicals, Inc.	1982-03-04	24
K820345	CALI-LOOP	Carr-Scarborough Microbiologicals, Inc.	1982-03-04	24
K820043	TEK-PRO TEK-TATOR V ROTATOR & HUMIDIFY	American Dade	1982-01-28	21
K813640	MINIWASH II	Dynatech Corp.	1982-01-28	28
K812068	PROPOSED CONTROLS FOR DOSIMETRIC RELEASE	Hexcel Medical	1981-09-08	49

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