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

JOY — Predicate Candidate Screening

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

130 daysmedian FDA review time

277 days90th percentile

35clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K243144	X100/X100HT with Full Field Peripheral Blood Smear (PBS) App	Scopio Labs , Ltd.	2025-06-27	270	0
K221309	AI100 with Shonit	Sigtuple Technologies Pvt. , Ltd.	2023-09-19	502	0
K220013	X100HT with Slide Loader with Full Field Peripheral Blood Sm	Scopio Labs , Ltd.	2022-05-03	119	0
K200595	CellaVision DC-1, CellaVision DC-1 PPA	CellaVision AB	2020-10-16	224	0
K201301	X100 with Full Field Peripheral Blood Smear (PBS) Applicatio	Scopio Labs , Ltd.	2020-10-02	140	0
K182062	Sysmex UD-10, Fully Automated Urine Particle Digital Imaging	Sysmex America, Inc.	2018-10-30	90	0
K171315	Advanced RBC Application	CellaVision AB	2017-08-01	89	0
K102778	CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION	CellaVision AB	2011-09-16	357	0
K092116	EASYCELL CELL LOCATOR	Medica Corp.	2010-05-12	302	0
K092868	CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-1	CellaVision AB	2009-11-20	63	1
K080595	CELLAVISION DM96 WITH THE BODY FLUID APPLICATION	CellaVision AB	2008-12-05	277	0
K071398	SCANVIEW, MODEL SC-300	Applied Spectral Imaging , Ltd.	2007-10-04	136	0
K061602	DUET SYSTEM	Bioview , Ltd.	2007-01-23	229	0
K062755	IKONISCOPE ONCOFISH BLADDER TEST SYSTEM	Ikonisys, Inc.	2007-01-04	112	0
K061392	IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM	Ikonisys, Inc.	2006-08-01	74	0
K052577	IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM	Ikonisys, Inc.	2006-01-24	127	0
K050840	MODIFICATION TO DUET SYSTEM	Bioview , Ltd.	2005-08-16	137	0
K040591	DUET SYSTEM	Bioview , Ltd.	2004-09-16	192	0
K033840	CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER	CellaVision AB	2004-02-10	62	0
K030192	DUET SYSTEM	Bioview , Ltd.	2003-08-20	211	0
K003301	DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER	CellaVision AB	2001-03-15	146	0
K001420	SLIDESCAN	Applied Imaging Corp.	2000-08-30	117	0
K984188	AUTOMATED CELLULAR IMAGING SYSTEM (ACIS)	Chroma Vision Medical Systems, Inc.	1999-07-28	247	0
K982786	TRACCELL 2000 SLIDE MAPPING SYSTEM	Accumed Intl., Inc.	1998-10-16	67	0
K982301	MICRO21 WITH URINE SEDIMENT ANALYSIS	Triangle Biomedical Sciences, Inc.	1998-08-07	37	0
K980375	WINSCAN AUTOMATED IMAGING SYSTEM	Applied Imaging Corp.	1998-06-09	130	0
K973050	MICRO21 WITH WBC ESTIMATE	Triangle Biomedical Sciences, Inc.	1997-11-07	84	0
K971470	MICRO21 WITH CEREBROSPINAL FLUID	Triangle Biomedical Sciences, Inc.	1997-09-16	147	0
K964689	TRACCELL 2000 SLIDE MAPPING SYSTEM	Accumed Intl., Inc.	1997-08-18	269	0
K970824	MDX 2000, DIGITAL ANALYZER	Shotwell & Carr, Inc.	1997-05-30	85	0
K960774	MICRO21 WITH ANA	Triangle Biomedical Sciences, Inc.	1996-05-22	86	0
K960776	MICRO21 WITH RETIC	Triangle Biomedical Sciences, Inc.	1996-05-17	81	0
K925670	IMS-200	Intelligent Medica Imaging, Inc.	1993-07-23	255	0
K772139	RE-CELL SLIDE RECAP	Geometric Data, Div. Smithkline Corp.	1978-01-05	52	0
K772140	SCANNING SYS., AUTO. COMP., ACS1000	Honeywell, Inc.	1977-12-05	21	0

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