Atlas FDA

KPA

21 FDA 510(k) clearances · Product code

35 daysmedian time to decision
71 days90th percentile
21clearances measured

FDA profile

Official device name
Slide Stainer, Automated
Device class
Class I (low risk)
Regulation
21 CFR 864.3800
Medical specialty
Pathology
Adverse events (MAUDE)
2021: 323 · 2022: 161 · 2023: 125 · 2024: 99 · 2025: 56 · 2026: 14
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
PROFIBLOT (K933996)Tecan U.S., Ltd.1994-01-28
VERSABLOT (K884258)American Bionetics, Inc.1988-12-14
WESCOR MODEL 7300 AEROSPRAY GRAM STAINER (K881592)Wescor, Inc.1988-05-13
LX-100 SLIDE STAINER (K880745)Innovative Medical Systems, Inc.1988-04-27
WESBLOT PROCESSOR (K874887)American Bionetics, Inc.1988-03-24
SAKURA DRS-60 AUTOMATIC SLIDE STAINER (K874897)Sakura Finetek U.S.A., Inc.1988-01-05
HISTOMATIC SLIDE STAINER, CODE-ON VERSION (K872916)Fisher Scientific Co., LLC1987-09-14
MST-1050-II X-RAY UNIT (K853210)Radiological Engineering, Inc.1985-10-10
CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERS (K850157)Shaban Mfg. Co.1985-02-27
PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERS (K850333)Shaban Mfg. Co.1985-02-27
MIDAS II AUTOMATIC STAINER (K842077)Innovative Medical Systems, Inc.1984-07-27
WESCOR 7100 AEROSPRAY SLIDE STAINER (K833295)Wescor, Inc.1983-10-31
MIDAS 6000 AUTOMATIC STAINER (K832994)Innovative Medical Systems, Inc.1983-09-29
MI DAS 1000 AUTOMATIC SLIDE STAINER (K821830)Innovative Medical Systems, Inc.1982-07-22
GUAMSTAINER (K811697)Tomtec1981-07-02
TECHNICON AUTOSLIDE STAINING/PROCESSING (K781598)Technicon Instruments Corp.1978-10-17
HEMATOLOGY SLIDE STAINER (K780637)A. J. P. Scientific, Inc.1978-05-19
AUTO. SLIDE STAINER (K780017)Honeywell, Inc.1978-01-30
CARA-STAIN MODEL 3000 (K771699)American Safety Equipment Corp.1977-09-13
HEMA-TEK II SLIDE STAINER (K771559)Miles Laboratories, Inc.1977-08-25
BIO-DYES FORT. WRIGHTS STAIN HEMAT. PACK (K770076)Jack W. Kindberg1977-03-22

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Every clearance here is in the API, with alerts when new ones post.