510(k) · Cleared

Cleared

CipherOx CRI M1

K173929510(k) TraditionalCleared Jul 24, 2018210-day reviewClass II21 CFR 870.2200

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Flashback Technologies, Inc. · PPW Adjunctive Cardiovascular Status Indicator

Cleared on Jul 24, 2018 as substantially equivalent to DEN160020 (Flashback Technologies, Inc., 2016) after a 210-day review. Its family tree reaches back 1 generation to 2016. 1 later device descends from it.

Decided: Jul 24, 2018
Review: 210 days
Class: Class II
Product code: PPW
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to DEN160020 (2016). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backDEN160020 CipherOx CRI TabletFlashback Technologies, Inc. · 2016
This deviceK173929 CipherOx CRI M1Flashback Technologies, Inc. · 2018
Descendant · cites it directly · 0 of its ownK252204 prolaio eVO2peak Module (Version 1.0)Prolaio, Inc. · 2025

Most influential descendants

Showing 1 of 1 · See all

K252204prolaio eVO2peak Module (Version 1.0)Prolaio, Inc. · 2025 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	DEN160020	CipherOx CRI Tablet	Flashback Technologies, Inc.	2016	—
0 (this device)	K173929	CipherOx CRI M1	Flashback Technologies, Inc.	2018	—
+1	K252204	prolaio eVO2peak Module (Version 1.0)	Prolaio, Inc.	2025	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2025	1	0

FIG. 1 — Lineage of K173929, 2016–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in PPW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new PPW device

#1 K213230 T3 Platform Softwarescore 15.8 · 12 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	DEN160020	CipherOx CRI Tablet Summary page 4 …Procode – PPW Adjunctive cardiovascular status indicator Class II Predicate Device: DEN160020- Flashback Technologies – CipherOx CRI™ Tablet Device Description: The CipherOx CRI™ M1 is a modification of the predicate devic…	Flashback Technologies, Inc.	2016	—
†	K080255	Nonin Medical, Inc., Model 7500 Digital Pulse Oximeter	Nonin Medical, Inc.	2008	—

Also cleared against DEN160020: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K252204	prolaio eVO2peak Module (Version 1.0)	Prolaio, Inc.	2025	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K252204 (Prolaio, Inc., 2025) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate DEN160020.

How does its category compare?

All PPW devices

PPW Adjunctive Cardiovascular Status Indicator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · PPW

2in 2025

2007high 2 (2022) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PPW

Too few PPW 510(k)s in any year since 2007 to give a median.

Recalls per year · PPW

No recall names PPW since 2007.

Adverse event reports per year · PPW

No MAUDE report names PPW since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	1	—	0
2017	0	—	0
2018	1	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	2	—	0
2023	1	—	0
2024	0	—	0
2025	2	—	0
2026	1	—	—

What is it indicated for?

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…

Read the full statement (124 words)

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K173929 · printed Nov 6, 2026

Cite this page

510(k) Report. “K173929: CipherOx CRI M1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173929

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026