CipherOx CRI Tablet
FDA 510(k) K213255 · Flashback Technologies, Inc.
510(k) numberK213255
Submission
- Device name
- CipherOx CRI Tablet
- Applicant
- Flashback Technologies, Inc.
Westfield, NJ, US - Received
- September 30, 2021
- Decision date
- June 17, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PPW – Adjunctive Cardiovascular Status Indicator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2200
- Specialty
- Cardiovascular
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.
Other 510(k)s with product code PPW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254066 | Etiometry PlatformPPW · Special | Etiometry, Inc. | 04/03/2026SE |
| K252204 | prolaio eVO2peak Module (Version 1.0)PPW · Traditional | Prolaio, Inc. | 12/16/2025SE |
| K241479 | Etiometry Platform (DAV 5.4 RAE 9.2)PPW · Traditional | Etiometry, Inc. | 02/12/2025SE |
| K223578 | T3 Platform softwarePPW · Traditional | Etiometry, Inc. | 07/07/2023SE |
| K213230 | T3 Platform SoftwarePPW · Traditional | Etiometry, Inc. | 06/22/2022SE |
| K173929 | CipherOx CRI M1PPW · Traditional | Flashback Technologies, Inc. | 07/24/2018SE |
More from Flashback Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K173929 | CipherOx CRI M1PPW · Traditional | 07/24/2018SE |
Questions and answers
When was CipherOx CRI Tablet cleared by the FDA?
CipherOx CRI Tablet (K213255) received a 510(k) decision of Substantially Equivalent on June 17, 2022, 260 days after the submission was received.
What is the product code of K213255?
The FDA product code is PPW – Adjunctive Cardiovascular Status Indicator, a Class II (moderate risk) device regulated under 21 CFR 870.2200.