FDA product code JPA: System, Multipurpose For In Vitro Coagulation Studies
JPA is the FDA product code for system, multipurpose for in vitro coagulation studies. It is a Class II device, regulated under 21 CFR 864.5425 and reviewed by the Hematology panel. FDA has cleared 181 510(k) submissions under JPA, 9 in the last five years, from 68 different applicants. The average 510(k) review took 118 days (median 81); 155 days on average over the last three years. FDA has posted 43 recalls for JPA devices, 6 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Multipurpose For In Vitro Coagulation Studies |
| Device class | Class II |
| Regulation | 21 CFR 864.5425 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for JPA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 171 |
| 2018 | 1 | 219 |
| 2019 | 3 | 152 |
| 2021 | 1 | 518 |
| 2022 | 1 | 767 |
| 2023 | 3 | 410 |
| 2024 | 1 | 266 |
| 2025 | 3 | 40 |
| 2026 | 1 | 158 |
Compare with all 510(k) review times · Search every JPA clearance
Top JPA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bio/Data Corp. | 13 | 1989-06-23 |
| Dade Behring, Inc. | 12 | 2003-01-16 |
| Instrumentation Laboratory CO | 11 | 2023-09-29 |
| International Technidyne Corp. | 9 | 2005-02-10 |
| Helena Laboratories | 8 | 2006-05-10 |
63 more applicants have JPA clearances. See the full list in Caduvo.
Most recent JPA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253658 | Diagnostica Stago, Inc. | STA Satellite Max® | 2026-04-27 | 158 |
| K250965 | Sysmex America, Inc. | Automated Blood Coagulation Analyzer CN-Series (CN-6000) | 2025-06-02 | 63 |
| K251024 | Haemonetics | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge | 2025-04-30 | 28 |
| K243858 | Haemonetics Corporation | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge | 2025-01-15 | 30 |
| K232018 | Haemonetics Corporation | Citrated: K, KH, RTH, FFH | 2024-03-29 | 266 |
Recalls for JPA devices
43 product recalls in 31 recall events; 6 initiated in the last five years and 5 still open. Most recent: 2025-07-21.
| Year | Recalls |
|---|---|
| 2019 | 3 |
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 2 |
| 2023 | 3 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code JPA?
JPA is the FDA product code for system, multipurpose for in vitro coagulation studies. It is a Class II device, regulated under 21 CFR 864.5425 and reviewed by the Hematology panel.
What device class is JPA?
Class II, regulation 21 CFR 864.5425. Typical premarket route: 510(k).
How long does a 510(k) take for product code JPA?
Across 181 cleared submissions the average was 118 days from receipt to decision (median 81).
Which companies have the most JPA clearances?
Bio/Data Corp. (13); Dade Behring, Inc. (12); Instrumentation Laboratory CO (11); International Technidyne Corp. (9); Helena Laboratories (8).
Have JPA devices been recalled?
Yes: 43 product recalls across 31 recall events; the most recent began 2025-07-21.
Next steps
- Run an FDA pathway report with predicate devices for product code JPA
- Run a recall and safety report across every JPA manufacturer
- Watch product code JPA 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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