510(k) · Cleared
ClearedVyntus Walk
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carefusion Germany 234 GmbH · DQA Oximeter
Cleared on Mar 20, 2015 as substantially equivalent to K092324 (Viasys Healthcare GmbH, 2009) after a 157-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Mar 20, 2015
- Review
- 157 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K000648 (2000). 6 ancestors in all, the oldest K980876 (1998). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000648 | Spiro Pro | Erich Jaeger GmbH | 2000 | — |
| −2 | K031515 | Spiropro SPO2 | Viasys Healthcare GmbH | 2003 | — |
| −1 | K092324 | Spiropro | Viasys Healthcare GmbH | 2009 | — |
| 0 (this device) | K142959 | Vyntus Walk | Carefusion Germany 234 GmbH | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2009 | 1 | 0 |
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 DQA? 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 DQA device
- #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 | Decided |
|---|---|---|---|
| * | K092324 | SpiroproSummary page 6…74 Cardiovascular Part 870 Code DQA 5.8 Reason for Premarket Notification • New Medical App 5.9 Legally predicate marketed devices • SpiroPro K092324 Code DQA, BTY 5.10 Predicate Device Company • VIASYS (now CareFusion Germany 234 GmbH) 5.11 Device Description… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- None of the 6 ancestors has a recall.
- 2 other devices also cite its predicate K092324.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · DQA
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQA
182in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQA
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQA
399in 2025
MAUDE reports naming product code DQA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 20 | 122 | 6 | 325 |
| 2008 | 22 | 97 | 5 | 312 |
| 2009 | 35 | 117 | 29 | 281 |
| 2010 | 29 | 127 | 4 | 185 |
| 2011 | 15 | 195 | 1 | 164 |
| 2012 | 14 | 120 | 0 | 322 |
| 2013 | 15 | 182 | 0 | 468 |
| 2014 | 11 | 175 | 2 | 1,124 |
| 2015 | 13 | 158 | 1 | 2,082 |
| 2016 | 14 | 246 | 0 | 1,775 |
| 2017 | 9 | 200 | 0 | 1,190 |
| 2018 | 18 | 260 | 32 | 694 |
| 2019 | 19 | 158 | 0 | 548 |
| 2020 | 15 | 126 | 0 | 426 |
| 2021 | 10 | 174 | 0 | 553 |
| 2022 | 20 | 265 | 0 | 478 |
| 2023 | 13 | 317 | 0 | 392 |
| 2024 | 14 | 285 | 3 | 545 |
| 2025 | 15 | 182 | 0 | 399 |
| 2026 | 8 | 187 | 0 | — |
What is it indicated for?
Vyntus Walk is a mobile medical application which is intended to be used on a mobile platform to collect and collate sequential pulse oximetry data during six minute walk tests (6MWT). Pulse oximetry data are collected from an external pulse oximeter, using Bluetooth connection. The mobile platform has access to a host computer with SQL database (SentrySuite) via a wireless network for further data evaluation and diagnosis. Patients as young as 4 years…
Read the full statement (109 words)
Vyntus Walk is a mobile medical application which is intended to be used on a mobile platform to collect and collate sequential pulse oximetry data during six minute walk tests (6MWT). Pulse oximetry data are collected from an external pulse oximeter, using Bluetooth connection. The mobile platform has access to a host computer with SQL database (SentrySuite) via a wireless network for further data evaluation and diagnosis. Patients as young as 4 years of age and older can be tested providing they can cooperate with the test instructions. Measurements are performed under the direction of a physician in a hospital environment, physician’s office or similar setting (professional healthcare facilities).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142959 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142959: Vyntus Walk.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142959
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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