510(k) · Cleared
ClearedUbiqVue™ 2A Multi-parameter System (UX2550)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lifesignals, Inc. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Nov 12, 2024 as substantially equivalent to K202868 (Lifesignals, Inc., 2021) and 1 other predicate after a 125-day review. Its family tree reaches back 21 generations to 1997. 1 of the 170 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Nov 12, 2024
- Review
- 125 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 21 generations to K962603 (1997). 167 ancestors in all, the oldest K822055 (1982). 2 later devices descend from it, 2 citing it directly. 1 of the 170 devices in this family, counting this one, has a Class I recall.
- Root · 21 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 17 generations between
- 3 generations backK150314 Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2015
- 2 generations backK181956 Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2019
- 1 generation backK212153 Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd. · 2022
- This deviceK242018 UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK260157 LifeLens Physiological MonitorLifeLens Technologies, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK252984 Perin Health System (PHD80060-2)Perin Health Devices, LLC · 2026
Show all 21 generations
- Root · 21 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 20 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 19 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 18 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 17 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 16 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 15 generations backK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
- 14 generations backK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
- 13 generations backK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
- 12 generations backK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
- 11 generations backK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
- 10 generations backK091241 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse…Masimo Corporation · 2009
- 9 generations backK100428 Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation · 2010
- 8 generations backK110516 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011
- 7 generations backK112687 Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011
- 6 generations backK121013 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2012
- 5 generations backK140188 Masimo Root Monitoring SystemMasimo Corporation · 2014
- 4 generations backK142394 Masimo Root Monitoring System and AccesoriesMasimo Corporation · 2014
- 3 generations backK150314 Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2015
- 2 generations backK181956 Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2019
- 1 generation backK212153 Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd. · 2022
- This deviceK242018 UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc. · 2024
Class I recalls in this family
- K970209 Capnocheck Plus9 generations back · 1997
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −20 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −19 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −18 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −17 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −16 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −15 | K033048 | Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL… | Cas Medical Systems, Inc. | 2004 | 1 |
| −14 | K050844 | 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL… | Cas Medical Systems, Inc. | 2005 | — |
| −13 | K060065 | CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter… | Oridion Capnography, Inc. | 2006 | 3 |
| −12 | K072295 | Capnostream 20 with A2 Adaptive Averaging Software | Oridion Capnography, Inc. | 2007 | — |
| −11 | K082268 | CAPNOSTREAM20 with Integrated Pulmonary Index | Oridion Capnography, Inc. | 2009 | 9 |
| −10 | K091241 | Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter | Masimo Corporation | 2009 | — |
| −9 | K100428 | Masimo Rainbow Set Radical 7R Pulse CO-Oximeter | Masimo Corporation | 2010 | — |
| −8 | K110516 | Connex Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2011 | — |
| −7 | K112687 | Connex (R) Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2011 | — |
| −6 | K121013 | Connex Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2012 | — |
| −5 | K140188 | Masimo Root Monitoring System | Masimo Corporation | 2014 | — |
| −4 | K142394 | Masimo Root Monitoring System and Accesories | Masimo Corporation | 2014 | — |
| −3 | K150314 | Masimo MightySat Rx Fingertip Pulse Oximeter | Masimo Corporation | 2015 | — |
| −2 | K181956 | Masimo MightySat Rx Fingertip Pulse Oximeter | Masimo Corporation | 2019 | — |
| −1 | K212153 | Biobeat Platform, BB-613WP Patch | Biobeat Technologies, Ltd. | 2022 | — |
| 0 (this device) | K242018 | UbiqVue™ 2A Multi-parameter System (UX2550) | Lifesignals, Inc. | 2024 | — |
| +1 | K260157 | LifeLens Physiological Monitor | LifeLens Technologies, Inc. | 2026 | — |
| +1 | K252984 | Perin Health System (PHD80060-2) | Perin Health Devices, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 5 | 0 |
| 1992 | 4 | 0 |
| 1993 | 4 | 0 |
| 1994 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 4 | 0 |
| 1997 | 5 | 1 |
| 1998 | 7 | 0 |
| 1999 | 4 | 0 |
| 2000 | 15 | 0 |
| 2001 | 3 | 0 |
| 2002 | 10 | 0 |
| 2003 | 8 | 0 |
| 2004 | 9 | 0 |
| 2005 | 12 | 0 |
| 2006 | 7 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 2 | 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.
1 device in this family has a Class I recall. 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 DRG device
- #1 K223711 ANNE Onescore 20.8 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K202868 | LifeSignals Multi-Parameter Remote Monitoring PlatformSummary page 6…DQA Oximeter Class II 6 Predicate & Reference Devices Primary Predicate Device: 510(k) Number : K202868 Model : LifeSignals Multiparameter Remote Monitoring Platform Manufacturer : LifeSignals, In… | 2021 |
| * | K212153 | Biobeat Platform, BB-613WP PatchSummary page 6…orm Manufacturer : LifeSignals, Inc. USA Secondary Predicate (for SpO2 , Pusle Rate & Body temperature intended use): 510(k) Number : K212153 Model : Biobeat Platform, BB-613WP Patch Manufacturer : Biobeat Technologies Ltd. Israel… | 2022 |
| † | K183078 | VitalConnect Platform, VitalPatch Biosensor | 2019 |
| † | K200160 | 740 SafeSAT | 2021 |
| † | K160951 | Philips Efficia CMS200 Central Monitoring System | 2016 |
| † | K203215 | Radius T wearable thermometer | 2021 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K970209Capnocheck PlusBci Intl., Inc. · 1997 · 9 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 27 years and passes through 9 companies; a new generation was cleared every 11 months on median.
- 25 of the 167 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K260157 (LifeLens Technologies, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DRG devicesDRG Transmitters And Receivers, Physiological Signal, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · DRG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRG
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRG
3in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRG
52in 2025
MAUDE reports naming product code DRG, 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 | 6 | 63 | 3 | 14 |
| 2008 | 5 | 74 | 0 | 9 |
| 2009 | 13 | 94 | 0 | 5 |
| 2010 | 10 | 68 | 0 | 13 |
| 2011 | 9 | 104 | 0 | 12 |
| 2012 | 12 | 103 | 0 | 9 |
| 2013 | 13 | 146 | 0 | 13 |
| 2014 | 10 | 177 | 0 | 97 |
| 2015 | 2 | — | 0 | 131 |
| 2016 | 2 | — | 0 | 182 |
| 2017 | 7 | 98 | 0 | 484 |
| 2018 | 6 | 220 | 0 | 166 |
| 2019 | 5 | 122 | 0 | 70 |
| 2020 | 6 | 159 | 0 | 82 |
| 2021 | 2 | — | 0 | 107 |
| 2022 | 6 | 287 | 0 | 43 |
| 2023 | 4 | 212 | 0 | 19 |
| 2024 | 3 | 125 | 0 | 26 |
| 2025 | 3 | 127 | 0 | 52 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The UbiqVue 2A Multiparameter System is a wireless remote patient monitoring system intended for use by healthcare professionals for continuous collection of physiological data at home and in healthcare settings. This shall include electrocardiography (2-Channel ECG), heart Rate, SpO2%, respiration rate, pulse Rate, photoplethysmography waveform, skin temperature, body temperature, body posture, body motion, R-R Interval, heart Rate variability (HRV) and…
Read the full statement (177 words)
The UbiqVue 2A Multiparameter System is a wireless remote patient monitoring system intended for
use by healthcare professionals for continuous collection of physiological data at home and in
healthcare settings. This shall include electrocardiography (2-Channel ECG), heart Rate, SpO2%,
respiration rate, pulse Rate, photoplethysmography waveform, skin temperature, body temperature,
body posture, body motion, R-R Interval, heart Rate variability (HRV) and blood Pressure (optional).
Data is transmitted wirelessly near real time from UbiqVue 2A Wearable Biosensor and 3rd party
device (for Blood Pressure only) to remote central server for display, storage, and analysis.
The UbiqVue 2A Multiparameter System is intended for non-critical, adult population.
The UbiqVue 2A Multiparameter System shall include the ability to notify healthcare professionals
through alerts when physiological parameters fall outside the set limits, manual trigger by the
patient and to display multiple patient's physiological data for remote monitoring at home and with
visual alarm for active monitoring at hospitals and out-of-hospital patient care settings (such as
clinics, outpatient surgery facilities, long-term care facilities and physician offices) in which care is
administered by healthcare professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242018 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242018: UbiqVue™ 2A Multi-parameter System (UX2550).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242018
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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