# DEN160020: CipherOx CRI Tablet

- Pathway: De Novo (Direct)
- Applicant: Flashback Technologies, Inc.
- Decided: Dec 21, 2016 after 211 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
No predicates in its family tree.
15 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K213230: T3 Platform Software (2022), 12 descendants of its own
- K222463: EchoGo Heart Failure (2022), 7 descendants of its own
- K240860: EchoGo Amyloidosis (1.0) (2024), 2 descendants of its own
- K223578: T3 Platform software (2023), 2 descendants of its own
- K213423: T3 Platform software (2023), 2 descendants of its own

## Indications for use
The CipherOx CRI Tablet 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/DEN160020
Methodology: https://510kreport.com/methodology