Adjunctive Cardiovascular Status Indicator
The Adjunctive Cardiovascular Status Indicator is a prescription device based on sensor technology that measures physical parameters to provide information about cardiovascular status, intended for adjunctive use alongside other vital signs and patient information rather than for independent therapy direction. It is classified as FDA Class 2 under 21 CFR 870.2200 in the Cardiovascular specialty, requiring 510(k) premarket notification. The device supports clinical decision-making as a supplementary tool. Product code PPW; not an implant and not life-sustaining.
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Basic Information
- Product Code
- PPW
- Device Class
- FDA class 2
- Regulation Number
- 870.2200
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K254066 | Etiometry Platform | Apr 03, 2026 | Substantially Equivalent | Etiometry, Inc. |
| K252204 | prolaio eVO2peak Module (Version 1.0) | Dec 16, 2025 | Substantially Equivalent | Prolaio, Inc. |
| K241479 | Etiometry Platform (DAV 5.4 RAE 9.2) | Feb 12, 2025 | Substantially Equivalent | Etiometry, Inc. |
| K223578 | T3 Platform software | Jul 07, 2023 | Substantially Equivalent | Etiometry, Inc. |
| K213230 | T3 Platform Software | Jun 22, 2022 | Substantially Equivalent | Etiometry, Inc. |
| K213255 | CipherOx CRI Tablet | Jun 17, 2022 | Substantially Equivalent | Flashback Technologies, Inc. |
| K173929 | CipherOx CRI M1 | Jul 24, 2018 | Substantially Equivalent | Flashback Technologies, Inc. |
| DEN160020 | CipherOx CRI Tablet | Dec 21, 2016 | Unknown | Flashback Technologies, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.