# K173929: CipherOx CRI M1

- Pathway: 510(k) (Traditional)
- Applicant: Flashback Technologies, Inc.
- Decided: Jul 24, 2018 after 210 days
- Product code: PPW (Adjunctive Cardiovascular Status Indicator)
- Device class: 2
- Regulation: 21 CFR 870.2200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN160020 (2016). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN160020: CipherOx CRI Tablet, Flashback Technologies, Inc. (2016) Summary page 4.

## Most influential descendants
- K252204: prolaio eVO2peak Module (Version 1.0) (2025), 0 descendants of its own

## Indications for use
The CipherOx™ CRI M1 is indicated for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂), pulse rate (measured by an SpO₂ sensor), and the Compensatory Reserve Index (CRI), which trends changes in intravascular volume relative to the individual patient’s response to hypovolemia. For patients with a finger thickness of 0.3” to 1” in hospital and pre-hospital settings. CRI trends with changes in intravascular volume relative to the individual patient’s response to hypovolemia, and should only be used by qualified medical providers as an adjunct to rather than as a replacement for traditional hemodynamic measures. CRI is indicated for adults (19-36 years old) in the supine position under non-motion conditions and without cardiovascular disease. CRI has not been studied in trauma patients.

Source page: https://510kreport.com/device/K173929
Methodology: https://510kreport.com/methodology