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CipherOx CRI Tablet

FDA 510(k)

Class II (US FDA 510(k))

510(k) K213255

by Flashback Technologies, Inc.

Identifiers

510(k) Number
K213255 FDA 510(k)
FDA Product Code
PPW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2200 FDA 510(k)
Regulation Number
870.2200 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The CipherOx CRI Tablet is a continuous, multi-parameter monitor that displays SpO2, Heart Rate (HR), photoplethysmograph (PPG) waveform images, and the Compensatory Reserve Index (CRI) value and historical trend-line. It is classified as an Adjunctive Cardiovascular Status Indicator and is intended to help detect and trend acute blood loss.

The device is supplied by Flashback Technologies, Inc. and has received FDA 510(k) clearance with number K213255. It is a Class II medical device with product code PPW and regulation number 870.2200. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided.

Frequently asked questions

What is the CipherOx CRI Tablet used for?

The CipherOx CRI Tablet is a continuous, multi-parameter monitor that displays SpO2, Heart Rate, photoplethysmograph waveform images, and the Compensatory Reserve Index value and historical trend-line. It is intended to help detect and trend acute blood loss as an Adjunctive Cardiovascular Status Indicator.

How is the CipherOx CRI Tablet supplied?

The device is supplied by Flashback Technologies, Inc. No information is provided regarding sterility, MRI safety, or storage conditions. It is not specified as single-use or reusable in the available data.

What regulatory approvals does the CipherOx CRI Tablet have?

The CipherOx CRI Tablet has received FDA 510(k) clearance with number K213255. It is classified as a Class II medical device with product code PPW and regulation number 870.2200. The device was cleared as substantially equivalent to predicate devices.

What parameters does the CipherOx CRI Tablet monitor?

The CipherOx CRI Tablet continuously monitors and displays four key parameters: SpO2 (oxygen saturation), Heart Rate (HR), photoplethysmograph (PPG) waveform images, and the Compensatory Reserve Index (CRI) value with its historical trend-line.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Flashback Technologies | CipherOx CRI-M1 | FDA-Cleared Hemorrhage Detection, CipherOx CRI Tablet (K213255) - FDA 510 (k), CipherOx CRI Tablet (K213255) — FDA 510 (k) | Innolitics, PDF De Novo Classification Request for Cipherox Cri Tablet

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Flashback Technologies, Inc.

Sources (1)

  • FDA 510(k) K213255 24 fields · synced Sep 24, 2026