FDA product code JOY: Device, Automated Cell-Locating
JOY is the FDA product code for device, automated cell-locating. It is a Class II device, regulated under 21 CFR 864.5260 and reviewed by the Hematology panel. FDA has cleared 35 510(k) submissions under JOY, 3 in the last five years, from 16 different applicants. The average 510(k) review took 158 days (median 130); 270 days on average over the last three years. FDA has posted 4 recalls for JOY devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Device, Automated Cell-Locating |
| Device class | Class II |
| Regulation | 21 CFR 864.5260 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for JOY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 89 |
| 2018 | 1 | 90 |
| 2020 | 2 | 182 |
| 2022 | 1 | 119 |
| 2023 | 1 | 502 |
| 2025 | 1 | 270 |
Compare with all 510(k) review times · Search every JOY clearance
Top JOY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| CellaVision AB | 7 | 2020-10-16 |
| Triangle Biomedical Sciences, Inc. | 5 | 1998-08-07 |
| Bioview , Ltd. | 4 | 2007-01-23 |
| Scopio Labs , Ltd. | 3 | 2025-06-27 |
| Ikonisys, Inc. | 3 | 2007-01-04 |
11 more applicants have JOY clearances. See the full list in Caduvo.
Most recent JOY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243144 | Scopio Labs , Ltd. | X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application | 2025-06-27 | 270 |
| K221309 | Sigtuple Technologies Pvt. , Ltd. | AI100 with Shonit | 2023-09-19 | 502 |
| K220013 | Scopio Labs , Ltd. | X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application | 2022-05-03 | 119 |
| K200595 | CellaVision AB | CellaVision DC-1, CellaVision DC-1 PPA | 2020-10-16 | 224 |
| K201301 | Scopio Labs , Ltd. | X100 with Full Field Peripheral Blood Smear (PBS) Application | 2020-10-02 | 140 |
Recalls for JOY devices
4 product recalls in 4 recall events; 1 initiated in the last five years and 2 still open. Most recent: 2025-10-08.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code JOY?
JOY is the FDA product code for device, automated cell-locating. It is a Class II device, regulated under 21 CFR 864.5260 and reviewed by the Hematology panel.
What device class is JOY?
Class II, regulation 21 CFR 864.5260. Typical premarket route: 510(k).
How long does a 510(k) take for product code JOY?
Across 35 cleared submissions the average was 158 days from receipt to decision (median 130).
Which companies have the most JOY clearances?
CellaVision AB (7); Triangle Biomedical Sciences, Inc. (5); Bioview , Ltd. (4); Scopio Labs , Ltd. (3); Ikonisys, Inc. (3).
Have JOY devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2025-10-08.
Next steps
- Run an FDA pathway report with predicate devices for product code JOY
- Run a recall and safety report across every JOY manufacturer
- Watch product code JOY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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