PPW
8 FDA 510(k) clearances · Product code
219 daysmedian time to decision
266 days90th percentile
8clearances measured
FDA profile
- Official device name
- Adjunctive Cardiovascular Status Indicator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2200
- Medical specialty
- Cardiovascular
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Etiometry Platform (K254066) | Etiometry, Inc. | 2026-04-03 |
| prolaio eVO2peak Module (Version 1.0) (K252204) | Prolaio, Inc. | 2025-12-16 |
| Etiometry Platform (DAV 5.4 RAE 9.2) (K241479) | Etiometry, Inc. | 2025-02-12 |
| T3 Platform software (K223578) | Etiometry, Inc. | 2023-07-07 |
| T3 Platform Software (K213230) | Etiometry, Inc. | 2022-06-22 |
| CipherOx CRI Tablet (K213255) | Flashback Technologies, Inc. | 2022-06-17 |
| CipherOx CRI M1 (K173929) | Flashback Technologies, Inc. | 2018-07-24 |
| CipherOx CRI Tablet (DEN160020) | Flashback Technologies, Inc. | 2016-12-21 |
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Every clearance here is in the API, with alerts when new ones post.