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

KPA — Predicate Candidate Screening

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

35 daysmedian FDA review time

71 days90th percentile

21clearances measured

K-number	Device	Applicant	Decided	Review days
K933996	PROFIBLOT	Tecan U.S., Ltd.	1994-01-28	164
K884258	VERSABLOT	American Bionetics, Inc.	1988-12-14	64
K881592	WESCOR MODEL 7300 AEROSPRAY GRAM STAINER	Wescor, Inc.	1988-05-13	31
K880745	LX-100 SLIDE STAINER	Innovative Medical Systems, Inc.	1988-04-27	63
K874887	WESBLOT PROCESSOR	American Bionetics, Inc.	1988-03-24	114
K874897	SAKURA DRS-60 AUTOMATIC SLIDE STAINER	Sakura Finetek U.S.A., Inc.	1988-01-05	35
K872916	HISTOMATIC SLIDE STAINER, CODE-ON VERSION	Fisher Scientific Co., LLC	1987-09-14	52
K853210	MST-1050-II X-RAY UNIT	Radiological Engineering, Inc.	1985-10-10	71
K850157	CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERS	Shaban Mfg. Co.	1985-02-27	43
K850333	PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERS	Shaban Mfg. Co.	1985-02-27	30
K842077	MIDAS II AUTOMATIC STAINER	Innovative Medical Systems, Inc.	1984-07-27	65
K833295	WESCOR 7100 AEROSPRAY SLIDE STAINER	Wescor, Inc.	1983-10-31	38
K832994	MIDAS 6000 AUTOMATIC STAINER	Innovative Medical Systems, Inc.	1983-09-29	27
K821830	MI DAS 1000 AUTOMATIC SLIDE STAINER	Innovative Medical Systems, Inc.	1982-07-22	30
K811697	GUAMSTAINER	Tomtec	1981-07-02	16
K781598	TECHNICON AUTOSLIDE STAINING/PROCESSING	Technicon Instruments Corp.	1978-10-17	29
K780637	HEMATOLOGY SLIDE STAINER	A. J. P. Scientific, Inc.	1978-05-19	32
K780017	AUTO. SLIDE STAINER	Honeywell, Inc.	1978-01-30	27
K771699	CARA-STAIN MODEL 3000	American Safety Equipment Corp.	1977-09-13	7
K771559	HEMA-TEK II SLIDE STAINER	Miles Laboratories, Inc.	1977-08-25	10
K770076	BIO-DYES FORT. WRIGHTS STAIN HEMAT. PACK	Jack W. Kindberg	1977-03-22	68

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