510(k) · Cleared
ClearedLifeSignals Multi-Parameter Remote Monitoring Platform
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 Jul 21, 2021 as substantially equivalent to K163453 (Vitalconnect, Inc., 2017) after a 296-day review. Its family tree reaches back 10 generations to 1997. 3 later devices descend from it.
- Decided
- Jul 21, 2021
- Review
- 296 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K962603 (1997). 27 ancestors in all, the oldest K891104 (1989). 3 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 6 generations between
- 3 generations backK141167 Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay…Vitalconnect, Inc. · 2014
- 2 generations backK152139 Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc. · 2015
- 1 generation backK163453 VitalPatch® VitalConnect PlatformVitalconnect, Inc. · 2017
- This deviceK202868 LifeSignals Multi-Parameter Remote Monitoring PlatformLifesignals, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK242018 UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK260157 LifeLens Physiological MonitorLifeLens Technologies, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK252984 Perin Health System (PHD80060-2)Perin Health Devices, LLC · 2026
Show all 10 generations
- Root · 10 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 9 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 8 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 7 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 6 generations backK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
- 5 generations backK061993 Equivital, Model EQ-01Hidalgo Limited · 2006
- 4 generations backK113054 EquivitalHidalgo Limited · 2012
- 3 generations backK141167 Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay…Vitalconnect, Inc. · 2014
- 2 generations backK152139 Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc. · 2015
- 1 generation backK163453 VitalPatch® VitalConnect PlatformVitalconnect, Inc. · 2017
- This deviceK202868 LifeSignals Multi-Parameter Remote Monitoring PlatformLifesignals, Inc. · 2021
Most influential descendants
Showing 3 of 3 · See all- K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc. · 2024 · cites it directly2descendants
- K260157LifeLens Physiological MonitorLifeLens Technologies, Inc. · 2026 · 2 generations on0descendants
- K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −9 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −8 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −7 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −6 | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 | Welch Allyn Protocol, Inc. | 2001 | — |
| −5 | K061993 | Equivital, Model EQ-01 | Hidalgo Limited | 2006 | — |
| −4 | K113054 | Equivital | Hidalgo Limited | 2012 | — |
| −3 | K141167 | Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software… | Vitalconnect, Inc. | 2014 | — |
| −2 | K152139 | Vital Connect Platform, HealthPatch MD, VitalPatch | Vitalconnect, Inc. | 2015 | — |
| −1 | K163453 | VitalPatch® VitalConnect Platform | Vitalconnect, Inc. | 2017 | — |
| 0 (this device) | K202868 | LifeSignals Multi-Parameter Remote Monitoring Platform | Lifesignals, Inc. | 2021 | — |
| +1 | K242018 | UbiqVue™ 2A Multi-parameter System (UX2550) | Lifesignals, Inc. | 2024 | — |
| +2 | K260157 | LifeLens Physiological Monitor | LifeLens Technologies, Inc. | 2026 | — |
| +2 | K252984 | Perin Health System (PHD80060-2) | Perin Health Devices, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 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.
Planning a device in DRG? 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? (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 |
|---|---|---|---|
| * | K163453 | VitalPatch® VitalConnect PlatformSummary page 5…K202868 6 Predicate & Reference Devices Predicate Device : 510(k) Number : K163453 Model : VitalConnect Platform Manufacturer : Vital Connect, Inc. USA Reference Devi… | 2017 |
| † | K170973 | VitalWatch Software User Interface | 2017 |
| † | K200690 | LifeSignals ECG Remote Monitoring Patch Platform | 2020 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242018 | UbiqVue™ 2A Multi-parameter System (UX2550) | 2024 | 2 |
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 7 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 27 ancestors have a recall of any class.
- Of its descendants, K242018 (Lifesignals, Inc., 2024) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K163453.
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. 2021, 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 LifeSignals Multi-parameter Remote Monitoring Platform is a wireless remote 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, Respiration Rate, Skin Temperature & Posture. Data is transmitted wirelessly from LifeSignals Biosensor to Remote secure server for display, storage & analysis.…
Read the full statement (105 words)
The LifeSignals Multi-parameter Remote Monitoring Platform is a wireless remote 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, Respiration Rate, Skin Temperature & Posture. Data is transmitted wirelessly from LifeSignals Biosensor to Remote secure server for display, storage & analysis.
The LifeSignals Multi-parameter Remote Monitoring Platform is intended for non-critical, adult population.
The LifeSignals Multi parameter Remote Monitoring Platform can include the ability to notify healthcare professionals
when physiological parameters fall outside the set limits and to display multiple patient physiological data for remote
monitoring.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K202868 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202868: LifeSignals Multi-Parameter Remote Monitoring Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202868
Report an extraction error
Are you the manufacturer?
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