FDA product code PPW: Adjunctive Cardiovascular Status Indicator
PPW is the FDA product code for adjunctive cardiovascular status indicator. It is a Class II device, regulated under 21 CFR 870.2200 and reviewed by the Cardiovascular panel. FDA has cleared 7 510(k) submissions under PPW, 6 in the last five years, from 3 different applicants. The average 510(k) review took 211 days (median 219); 158 days on average over the last three years. 1 De Novo request was granted under it.
Definition
The adjunctive cardiovascular status indicator is a prescription device based on sensor technology for the measurement of a physical parameter(s). This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.
Classification
| Field | Value |
|---|---|
| Device name | Adjunctive Cardiovascular Status Indicator |
| Device class | Class II |
| Regulation | 21 CFR 870.2200 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for PPW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 210 |
| 2022 | 2 | 263 |
| 2023 | 1 | 219 |
| 2025 | 2 | 210 |
| 2026 | 1 | 106 |
Compare with all 510(k) review times · Search every PPW clearance
Top PPW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Etiometry, Inc. | 4 | 2026-04-03 |
| Flashback Technologies, Inc. | 2 | 2022-06-17 |
| Prolaio, Inc. | 1 | 2025-12-16 |
Most recent PPW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254066 | Etiometry, Inc. | Etiometry Platform | 2026-04-03 | 106 |
| K252204 | Prolaio, Inc. | prolaio eVO2peak Module (Version 1.0) | 2025-12-16 | 155 |
| K241479 | Etiometry, Inc. | Etiometry Platform (DAV 5.4 RAE 9.2) | 2025-02-12 | 264 |
| K223578 | Etiometry, Inc. | T3 Platform software | 2023-07-07 | 219 |
| K213230 | Etiometry, Inc. | T3 Platform Software | 2022-06-22 | 266 |
Recalls for PPW devices
openFDA lists no recalls for product code PPW.
Frequently asked questions
What is FDA product code PPW?
PPW is the FDA product code for adjunctive cardiovascular status indicator. It is a Class II device, regulated under 21 CFR 870.2200 and reviewed by the Cardiovascular panel.
What device class is PPW?
Class II, regulation 21 CFR 870.2200. Typical premarket route: 510(k).
How long does a 510(k) take for product code PPW?
Across 7 cleared submissions the average was 211 days from receipt to decision (median 219).
Which companies have the most PPW clearances?
Etiometry, Inc. (4); Flashback Technologies, Inc. (2); Prolaio, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PPW
- Run a recall and safety report across every PPW manufacturer
- Watch product code PPW 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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