510(k) · Cleared
ClearedVyvo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vyvo Technology Corp.(Vt) · DQA Oximeter
Cleared on Mar 4, 2024 as substantially equivalent to K181006 (Bio-Beat Technologies, Ltd., 2018) after a 305-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Mar 4, 2024
- Review
- 305 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K001085 (2000). No later device cites it as a predicate yet.
- Root · 6 generations backK001085 Modification to Onyx, Finger Clip Pulse Oximeter, Model 9500Nonin Medical, Inc. · 2000
- 5 generations backK051107 Onyx II Finger Pulse Oximeter, Model 9550Nonin Medical, Inc. · 2005
- 4 generations backK053130 Onyx II Finger Pulse Oximeter, Model 9550Nonin Medical, Inc. · 2006
- 3 generations backK112843 Pulse OximeterNonin Medical, Inc. · 2012
- 2 generations backK163382 Oxitone 1000Oxitone Medical, Ltd. · 2017
- 1 generation backK181006 BB-613 Watch OximeterBio-Beat Technologies, Ltd. · 2018
- This deviceK231288 VyvoVyvo Technology Corp.(Vt) · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001085 | Modification to Onyx, Finger Clip Pulse Oximeter, Model 9500 | Nonin Medical, Inc. | 2000 | — |
| −5 | K051107 | Onyx II Finger Pulse Oximeter, Model 9550 | Nonin Medical, Inc. | 2005 | — |
| −4 | K053130 | Onyx II Finger Pulse Oximeter, Model 9550 | Nonin Medical, Inc. | 2006 | — |
| −3 | K112843 | Pulse Oximeter | Nonin Medical, Inc. | 2012 | — |
| −2 | K163382 | Oxitone 1000 | Oxitone Medical, Ltd. | 2017 | — |
| −1 | K181006 | BB-613 Watch Oximeter | Bio-Beat Technologies, Ltd. | 2018 | — |
| 0 (this device) | K231288 | Vyvo | Vyvo Technology Corp.(Vt) | 2024 | — |
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 |
|---|---|---|---|
| * | K181006 | BB-613 Watch OximeterSummary page 5…and Reference Devices Predicate Device: Sponsor: Bio-Beat Technologies Ltd. Device: BB-613 Watch Oximeter 510(K) Number: K181006 Reference Device: Sponsor: Beijing Choice Electronic Technology Company, Limited Device: Wr… | 2018 |
| † | K122046 | Wrist Pulse Oximeter | 2013 |
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 24 years and passes through 4 companies; a new generation was cleared every 5.1 years on median.
- None of the 6 ancestors has a recall.
- 2 other devices also cite its predicate K181006.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
The VYVO Life Watch is a small, wrist-worn device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate. It is intended for spot-checking of adult patients in hospitals, clinics, long-term care, and home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231288 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231288: Vyvo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231288
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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