FDA product code PJA: Coronary Vascular Physiologic Simulation Software
PJA is the FDA product code for coronary vascular physiologic simulation software. It is a Class II device, regulated under 21 CFR 870.1415 and reviewed by the Cardiovascular panel. FDA has cleared 8 510(k) submissions under PJA, 3 in the last five years, from 2 different applicants. The average 510(k) review took 130 days (median 121); 114 days on average over the last three years. 1 De Novo request was granted under it.
Definition
A coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease.
Classification
| Field | Value |
|---|---|
| Device name | Coronary Vascular Physiologic Simulation Software |
| Device class | Class II |
| Regulation | 21 CFR 870.1415 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for PJA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 129 |
| 2019 | 1 | 128 |
| 2021 | 1 | 57 |
| 2022 | 2 | 220 |
| 2025 | 1 | 114 |
Compare with all 510(k) review times · Search every PJA clearance
Top PJA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| HeartFlow, Inc. | 7 | 2025-07-18 |
| Keyamed Na, Inc. | 1 | 2022-04-01 |
Most recent PJA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250902 | HeartFlow, Inc. | HeartFlow Analysis | 2025-07-18 | 114 |
| K213857 | HeartFlow, Inc. | HeartFlow Analysis | 2022-10-14 | 308 |
| K213657 | Keyamed Na, Inc. | DEEPVESSEL FFR | 2022-04-01 | 133 |
| K203329 | HeartFlow, Inc. | HeartFlow Analysis | 2021-01-08 | 57 |
| K190925 | HeartFlow, Inc. | HeartFlow FFRct Analysis | 2019-08-15 | 128 |
Recalls for PJA devices
openFDA lists no recalls for product code PJA.
Frequently asked questions
What is FDA product code PJA?
PJA is the FDA product code for coronary vascular physiologic simulation software. It is a Class II device, regulated under 21 CFR 870.1415 and reviewed by the Cardiovascular panel.
What device class is PJA?
Class II, regulation 21 CFR 870.1415. Typical premarket route: 510(k).
How long does a 510(k) take for product code PJA?
Across 8 cleared submissions the average was 130 days from receipt to decision (median 121).
Which companies have the most PJA clearances?
HeartFlow, Inc. (7); Keyamed Na, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PJA
- Run a recall and safety report across every PJA manufacturer
- Watch product code PJA 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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