510(k) · Cleared
ClearedWVSM (Wireless Vital Signs Monitor), Model 5.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Athena Gtx · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Jul 21, 2010 as substantially equivalent to K033378 (Welch Allyn Protocol, Inc., 2004) and 4 other predicates after a 36-day review. Its family tree reaches back 8 generations to 1997. 17 later devices descend from it.
- Decided
- Jul 21, 2010
- Review
- 36 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 8 generations to K962603 (1997). 30 ancestors in all, the oldest K904039 (1990). 17 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 7 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 6 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 5 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 4 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 3 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 2 generations backK031740 VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc. · 2003
- 1 generation backK033378 Vital Signs Monitor, Propaq LTWelch Allyn Protocol, Inc. · 2004 · Recalled
- This deviceK101674 WVSM (Wireless Vital Signs Monitor), Model 5.0Athena Gtx · 2010
- Descendant · cites it directly · 13 of its ownK113165 Mini-MedicAthena Gtx · 2012
- Descendant · 2 generations on · 12 of its ownK190792 BB-613WPBiobeat Technologies, Ltd. · 2019
- Descendant · 3 generations on · 5 of its ownK212153 Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd. · 2022
- Descendant · 4 generations on · 2 of its ownK242018 UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc. · 2024
- Descendant · 3 generations on · 2 of its ownK222658 Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc. · 2023
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K113165Mini-MedicAthena Gtx · 2012 · cites it directly13descendants
- K190792BB-613WPBiobeat Technologies, Ltd. · 2019 · 2 generations on12descendants
- K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd. · 2022 · 3 generations on5descendants
- K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc. · 2024 · 4 generations on2descendants
- K222658Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc. · 2023 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −7 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −6 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −5 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −4 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −3 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −2 | K031740 | VSM - Vital Signs Monitor, Model 53000 Series | Welch Allyn Protocol, Inc. | 2003 | — |
| −1 | K033378 | Vital Signs Monitor, Propaq LT | Welch Allyn Protocol, Inc. | 2004 | 3 |
| 0 (this device) | K101674 | WVSM (Wireless Vital Signs Monitor), Model 5.0 | Athena Gtx | 2010 | — |
| +1 | K113165 | Mini-Medic | Athena Gtx | 2012 | — |
| +2 | K190792 | BB-613WP | Biobeat Technologies, Ltd. | 2019 | — |
| +3 | K212153 | Biobeat Platform, BB-613WP Patch | Biobeat Technologies, Ltd. | 2022 | — |
| +4 | K242018 | UbiqVue™ 2A Multi-parameter System (UX2550) | Lifesignals, Inc. | 2024 | — |
| +3 | K222658 | Accurate 24 Non-invasive blood pressure monitor | Accurate Meditech, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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 MWI? 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 MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K033378 | Vital Signs Monitor, Propaq LTSummary page 1…gulation: Class II Basis for Submission: New device design Legally Marketed (Predicate) Devices: Welch Ally Propaq LT Vital Signs Monitor; (K033378) Nonin Medical, Inc. Model # 7500 Digital Pulse Oximeter (K071 285)… | 2004 |
| * | K071285 | Digital Pulse Oximeter, Model 7500Summary page 1…Welch Ally Propaq LT Vital Signs Monitor; (K033378) Nonin Medical, Inc. Model # 7500 Digital Pulse Oximeter (K071 285) HomnMed Genesis Patient Monitor System (K040799) Welch Allyn Acuity Ce… | 2007 |
| * | K040799 | Hommed Genesis Patient Monitor System with OptionsSummary page 1…Nonin Medical, Inc. Model # 7500 Digital Pulse Oximeter (K071 285) HomnMed Genesis Patient Monitor System (K040799) Welch Allyn Acuity Central Monitoring Station (K052160, K022453) Devic… | 2004 |
| * | K052160 | Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.)Summary page 1…HomnMed Genesis Patient Monitor System (K040799) Welch Allyn Acuity Central Monitoring Station (K052160, K022453) Device Description: The Athena GTX (WVSM) Wireless Vital Signs Monitor is a small,… | 2005 |
| * | K022453 | Modification to Acuity Central Monitoring SystemSummary page 1…HomnMed Genesis Patient Monitor System (K040799) Welch Allyn Acuity Central Monitoring Station (K052160, K022453) Device Description: The Athena GTX (WVSM) Wireless Vital Signs Monitor is a small, lightwei… | 2002 |
What descends from it? (17)
See all 173 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?
- The line of descent spans 13 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 9 of the 30 ancestors have a recall of any class.
- Of its descendants, K113165 (Athena Gtx, 2012) has gone furthest, with 13 descendants of its own.
- 5 other devices also cite its predicate K033378.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
MAUDE reports naming product code MWI, 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 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
What is it indicated for?
The Wireless Vital Signs Monitor (WV'SM) is intended to be used as an adult patient monitor. It is indicated as a single or multi-parameter vital signs monitor for ECG, noninvasive blood pressure (NIBP) and SpO2. It may be used in the following locations: Hospitals,,healthcare facilities. emergency medical applications, during transport, and other healthcare applications. The monitor uses wireless communications to transmit vital signs data to a handheld or PC computer. The monitor is intended to be used by trained healthcare providers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101674 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101674: WVSM (Wireless Vital Signs Monitor), Model 5.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101674
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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