JOY · Class II · 21 CFR 864.5260

FDA Product Code JOY: Device, Automated Cell-locating

Leading manufacturers include Triangle Biomedical Sciences, Inc., Scopio Labs , Ltd. and Accumed Intl., Inc..

35
Total
35
Cleared
158d
Avg days
1977
Since
Stable submission activity - 1 submissions in the last 2 years
Review times increasing: avg 270d recently vs 155d historically

FDA 510(k) Cleared Device, Automated Cell-locating Devices (Product Code JOY)

35 devices
1–24 of 35
Cleared Jun 27, 2025
X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application
K243144
Scopio Labs , Ltd.
Hematology · 270d
Cleared Sep 19, 2023
AI100 with Shonit
K221309
Sigtuple Technologies Pvt. , Ltd.
Hematology · 502d
Cleared May 03, 2022
X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application
K220013
Scopio Labs , Ltd.
Hematology · 119d
Cleared Oct 16, 2020
CellaVision DC-1, CellaVision DC-1 PPA
K200595
CellaVision AB
Hematology · 224d
Cleared Oct 02, 2020
X100 with Full Field Peripheral Blood Smear (PBS) Application
K201301
Scopio Labs , Ltd.
Hematology · 140d
Cleared Oct 30, 2018
Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device
K182062
Sysmex America, Inc.
Hematology · 90d
Cleared Aug 01, 2017
Advanced RBC Application
K171315
CellaVision AB
Hematology · 89d
Cleared May 12, 2010
EASYCELL CELL LOCATOR
K092116
Medica Corp.
Hematology · 302d
Cleared Aug 16, 2005
MODIFICATION TO DUET SYSTEM
K050840
Bioview , Ltd.
Hematology · 137d
Cleared Jul 28, 1999
AUTOMATED CELLULAR IMAGING SYSTEM (ACIS)
K984188
Chroma Vision Medical Systems, Inc.
Hematology · 247d
Cleared Oct 16, 1998
TRACCELL 2000 SLIDE MAPPING SYSTEM
K982786
Accumed Intl., Inc.
Hematology · 67d
Cleared Aug 07, 1998
MICRO21 WITH URINE SEDIMENT ANALYSIS
K982301
Triangle Biomedical Sciences, Inc.
Hematology · 37d
Cleared Jun 09, 1998
WINSCAN AUTOMATED IMAGING SYSTEM
K980375
Applied Imaging Corp.
Hematology · 130d
Cleared Nov 07, 1997
MICRO21 WITH WBC ESTIMATE
K973050
Triangle Biomedical Sciences, Inc.
Hematology · 84d
Cleared Sep 16, 1997
MICRO21 WITH CEREBROSPINAL FLUID
K971470
Triangle Biomedical Sciences, Inc.
Hematology · 147d
Cleared Aug 18, 1997
TRACCELL 2000 SLIDE MAPPING SYSTEM
K964689
Accumed Intl., Inc.
Hematology · 269d
Cleared May 30, 1997
MDX 2000, DIGITAL ANALYZER
K970824
Shotwell & Carr, Inc.
Hematology · 85d
Cleared May 22, 1996
MICRO21 WITH ANA
K960774
Triangle Biomedical Sciences, Inc.
Hematology · 86d
Cleared May 17, 1996
MICRO21 WITH RETIC
K960776
Triangle Biomedical Sciences, Inc.
Hematology · 81d
Cleared Jan 05, 1978
RE-CELL SLIDE RECAP
K772139
Geometric Data, Div. Smithkline Corp.
Hematology · 52d
Cleared Dec 05, 1977
SCANNING SYS., AUTO. COMP., ACS1000
K772140
Honeywell, Inc.
Hematology · 21d

About Product Code JOY - Regulatory Context

510(k) Submission Activity

35 total 510(k) submissions under product code JOY since 1977, with 35 receiving FDA clearance (average review time: 158 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - JOY Product Code

Recent submissions under JOY have taken an average of 270 days to reach a decision - up from 155 days historically. Manufacturers should account for longer review timelines in current project planning.

JOY devices are reviewed by the Hematology panel. Browse all Hematology devices →