FDA product code JOZ: System, Automated Platelet Aggregation
JOZ is the FDA product code for system, automated platelet aggregation. It is a Class II device, regulated under 21 CFR 864.5700 and reviewed by the Hematology panel. FDA has cleared 38 510(k) submissions under JOZ, from 20 different applicants. The average 510(k) review took 164 days (median 128). FDA has posted 11 recalls for JOZ devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Automated Platelet Aggregation |
| Device class | Class II |
| Regulation | 21 CFR 864.5700 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for JOZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 135 |
| 2019 | 1 | 269 |
| 2020 | 1 | 268 |
Top JOZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Accumetrics, Inc. | 7 | 2015-07-24 |
| Chrono-Log Corp. | 6 | 2016-12-02 |
| Helena Laboratories | 4 | 2003-02-14 |
| Aggredyne, Inc. | 3 | 2019-03-29 |
| Dade Behring, Inc. | 2 | 2006-07-21 |
15 more applicants have JOZ clearances. See the full list in Caduvo.
Most recent JOZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K191364 | Fujimori Kogyo, Co., Ltd. | T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01 | 2020-02-14 | 268 |
| K181777 | Aggredyne, Inc. | AggreGuide A-100 ADP | 2019-03-29 | 269 |
| K163274 | Aggredyne, Inc. | AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument | 2017-04-05 | 135 |
| K161329 | Chrono-Log Corp. | Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel | 2016-12-02 | 204 |
| K141427 | Accumetrics, Inc. | ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST | 2015-07-24 | 420 |
Recalls for JOZ devices
11 product recalls in 10 recall events; 3 initiated in the last five years and 2 still open. Most recent: 2025-10-21.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2022 | 1 |
| 2024 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code JOZ?
JOZ is the FDA product code for system, automated platelet aggregation. It is a Class II device, regulated under 21 CFR 864.5700 and reviewed by the Hematology panel.
What device class is JOZ?
Class II, regulation 21 CFR 864.5700. Typical premarket route: 510(k).
How long does a 510(k) take for product code JOZ?
Across 38 cleared submissions the average was 164 days from receipt to decision (median 128).
Which companies have the most JOZ clearances?
Accumetrics, Inc. (7); Chrono-Log Corp. (6); Helena Laboratories (4); Aggredyne, Inc. (3); Dade Behring, Inc. (2).
Have JOZ devices been recalled?
Yes: 11 product recalls across 10 recall events; the most recent began 2025-10-21.
Next steps
- Run an FDA pathway report with predicate devices for product code JOZ
- Run a recall and safety report across every JOZ manufacturer
- Watch product code JOZ 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.