De Novo · Granted
GrantedCipherOx CRI Tablet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Flashback Technologies, Inc. · PPW Adjunctive Cardiovascular Status Indicator
Granted on Dec 21, 2016 as a new device type through De Novo after a 211-day review. 15 later devices descend from it.
- Decided
- Dec 21, 2016
- Review
- 211 days
- Class
- Class II
- Product code
- PPW
- Recalls
- None
15 later devices descend from it, 2 citing it directly.
- This deviceDEN160020 CipherOx CRI TabletFlashback Technologies, Inc. · 2016
- Descendant · cites it directly · 12 of its ownK213230 T3 Platform SoftwareEtiometry, Inc. · 2022
- Descendant · 2 generations on · 7 of its ownK222463 EchoGo Heart FailureUltromics Limited · 2022
- Descendant · 3 generations on · 2 of its ownK240860 EchoGo Amyloidosis (1.0)Ultromics Limited · 2024
- Descendant · 2 generations on · 2 of its ownK223578 T3 Platform softwareEtiometry, Inc. · 2023
- Descendant · 2 generations on · 2 of its ownK213423 T3 Platform softwareEtiometry, Inc. · 2023
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K213230T3 Platform SoftwareEtiometry, Inc. · 2022 · cites it directly12descendants
- K222463EchoGo Heart FailureUltromics Limited · 2022 · 2 generations on7descendants
- K240860EchoGo Amyloidosis (1.0)Ultromics Limited · 2024 · 3 generations on2descendants
- K223578T3 Platform softwareEtiometry, Inc. · 2023 · 2 generations on2descendants
- K213423T3 Platform softwareEtiometry, Inc. · 2023 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN160020 | CipherOx CRI Tablet | Flashback Technologies, Inc. | 2016 | — |
| +1 | K213230 | T3 Platform Software | Etiometry, Inc. | 2022 | — |
| +2 | K222463 | EchoGo Heart Failure | Ultromics Limited | 2022 | — |
| +3 | K240860 | EchoGo Amyloidosis (1.0) | Ultromics Limited | 2024 | — |
| +2 | K223578 | T3 Platform software | Etiometry, Inc. | 2023 | — |
| +2 | K213423 | T3 Platform software | Etiometry, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 5 | 0 |
| 2026 | 1 | 0 |
Sources: FDA De Novo 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 15.9 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (15)
See all 152 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K213230 (Etiometry, Inc., 2022) has gone furthest, with 12 descendants of its own.
How does its category compare?
All PPW devicesPPW Adjunctive Cardiovascular Status Indicator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · PPW
2in 2025
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (124 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN160020 · printed Nov 4, 2026
Cite this page
510(k) Report. “DEN160020: CipherOx CRI Tablet.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/DEN160020
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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