510(k) · Cleared
ClearedLife Sensor Cardiac Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Braveheart Wireless, Inc. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Jun 12, 2019 as substantially equivalent to K172011 (Hmicro, Inc., 2018) after a 27-day review. Its family tree reaches back 13 generations to 1997.
- Decided
- Jun 12, 2019
- Review
- 27 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K962603 (1997). 62 ancestors in all, the oldest K872291 (1987). No later device cites it as a predicate yet.
- Root · 13 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 9 generations between
- 3 generations backK143751 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2015
- 2 generations backK150992 Vios Monitoring SystemVios Medical, Inc. · 2015
- 1 generation backK172011 LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals…Hmicro, Inc. · 2018
- This deviceK191331 Life Sensor Cardiac MonitorBraveheart Wireless, Inc. · 2019
Show all 13 generations
- Root · 13 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 12 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 11 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 10 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 9 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 8 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 7 generations backK031740 VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc. · 2003
- 6 generations backK033378 Vital Signs Monitor, Propaq LTWelch Allyn Protocol, Inc. · 2004 · Recalled
- 5 generations backK122036 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2012 · Recalled
- 4 generations backK133586 Visi Mobile Monitioring SystemSotera Wireless, Inc. · 2013
- 3 generations backK143751 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2015
- 2 generations backK150992 Vios Monitoring SystemVios Medical, Inc. · 2015
- 1 generation backK172011 LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals…Hmicro, Inc. · 2018
- This deviceK191331 Life Sensor Cardiac MonitorBraveheart Wireless, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −12 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −11 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −10 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −9 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −8 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −7 | K031740 | VSM - Vital Signs Monitor, Model 53000 Series | Welch Allyn Protocol, Inc. | 2003 | — |
| −6 | K033378 | Vital Signs Monitor, Propaq LT | Welch Allyn Protocol, Inc. | 2004 | 3 |
| −5 | K122036 | Visi Mobile Monitoring System | Sotera Wireless, Inc. | 2012 | 2 |
| −4 | K133586 | Visi Mobile Monitioring System | Sotera Wireless, Inc. | 2013 | — |
| −3 | K143751 | Visi Mobile Monitoring System | Sotera Wireless, Inc. | 2015 | — |
| −2 | K150992 | Vios Monitoring System | Vios Medical, Inc. | 2015 | — |
| −1 | K172011 | LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch &… | Hmicro, Inc. | 2018 | — |
| 0 (this device) | K191331 | Life Sensor Cardiac Monitor | Braveheart Wireless, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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 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 |
|---|---|---|---|
| * | K172011 | LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)Summary page 4…DRG, DRT, DRX III. Predicate Device Manufacturer: Life Signals, Inc Model Name: LifeSignals WiPatch & WiApp System 510(k) #: K172011 This predicate has not been subject to a design-related recall.… | 2018 |
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 22 years and passes through 8 companies; a new generation was cleared every 12 months on median.
- 11 of the 62 ancestors have a recall of any class.
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. 2019, 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 Life Sensor Cardiac Monitor (CM) is a wireless monitoring system intended for use by healthcare professionals for monitoring of physiological data within healthcare settings. This includes heart rate and electrocardiography (ECG). Data is transmitted wirelessly from Life Sensor Electrode to an application on iOS device where it is displayed for review by healthcare professionals. The device is intended for use on general care patients 18 years or…
Read the full statement (131 words)
The Life Sensor Cardiac Monitor (CM) is a wireless monitoring system intended for use by healthcare professionals for monitoring of physiological data within healthcare settings. This includes heart rate and electrocardiography (ECG). Data is transmitted wirelessly from Life Sensor Electrode to an application on iOS device where it is displayed for review by healthcare professionals. The device is intended for use on general care patients 18 years or older and by prescription only.
The device is contraindicated for use on critical care patients, patients with active implantable medical devices such as pacemakers, implanted cardioverter defibrillator (ICD), and left ventricular assist devices (LVAD); for use in magnetic resonance (MR) environments; for use during surgical procedures when electro-surgical equipment is optional. The Life Sensor Cardiac Monitor does not detect or diagnose medical conditions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191331 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191331: Life Sensor Cardiac Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191331
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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