510(k) · Cleared
Recalled · 2007Lifesyne Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gmp/Companies, Inc. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Aug 5, 2003 as substantially equivalent to K974149 (Mortara Instrument, Inc., 1998) after a 146-day review. Its family tree reaches back 2 generations to 1989. 109 later devices descend from it. It has been recalled 3 times.
- Decided
- Aug 5, 2003
- Review
- 146 days
- Class
- Class II
- Product code
- DRG
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 2 generations to K891104 (1989). 3 ancestors in all. 109 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK891104 CD Telemetry SystemsMarquette Electronics, Inc. · 1989
- 1 generation backK974149 Ambulatory X-12 Telemetry ModuleMortara Instrument, Inc. · 1998 · Recalled
- This deviceK030795 Lifesyne SystemsGmp/Companies, Inc. · 2003
- Descendant · cites it directly · 99 of its ownK061993 Equivital, Model EQ-01Hidalgo Limited · 2006
- Descendant · cites it directly · 71 of its ownK113054 EquivitalHidalgo Limited · 2012
- Descendant · 2 generations on · 70 of its ownK141167 Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay…Vitalconnect, Inc. · 2014
- Descendant · 3 generations on · 43 of its ownK152139 Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc. · 2015
- Descendant · 2 generations on · 22 of its ownK081140 VisensiaObs Medical · 2008
Showing 5 of 109 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 109 · See all- K061993Equivital, Model EQ-01Hidalgo Limited · 2006 · cites it directly99descendants
- K113054EquivitalHidalgo Limited · 2012 · cites it directly71descendants
- K141167Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software Library and…Vitalconnect, Inc. · 2014 · 2 generations on70descendants
- K152139Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc. · 2015 · 3 generations on43descendants
- K081140VisensiaObs Medical · 2008 · 2 generations on22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K891104 | CD Telemetry Systems | Marquette Electronics, Inc. | 1989 | — |
| −1 | K974149 | Ambulatory X-12 Telemetry Module | Mortara Instrument, Inc. | 1998 | 1 |
| 0 (this device) | K030795 | Lifesyne Systems | Gmp/Companies, Inc. | 2003 | — |
| +1 | K061993 | Equivital, Model EQ-01 | Hidalgo Limited | 2006 | — |
| +1 | K113054 | Equivital | Hidalgo Limited | 2012 | — |
| +2 | K141167 | Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software… | Vitalconnect, Inc. | 2014 | — |
| +3 | K152139 | Vital Connect Platform, HealthPatch MD, VitalPatch | Vitalconnect, Inc. | 2015 | — |
| +2 | K081140 | Visensia | Obs Medical | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 6 | 0 |
| 2019 | 9 | 0 |
| 2020 | 9 | 0 |
| 2021 | 5 | 0 |
| 2022 | 8 | 0 |
| 2023 | 13 | 0 |
| 2024 | 12 | 0 |
| 2025 | 16 | 0 |
| 2026 | 8 | 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 |
|---|---|---|---|
| * | K974149 | Ambulatory X-12 Telemetry ModuleSummary page 1…ICE The GMPl Wireless Medicine LifeSyncTMSystem is substantially equivalent to the Mortara Ambulatory X-12 Telemetry Module that was cleared by FDA under K974149 on January 8, 1998. B. DEVICE DESCRIPTION The GMPlWireless Medicine LifeSyncTMSystem is comprised of 4 primary comp… | 1998 |
What descends from it? (109)
See all 1094 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 13, 2007 | Not classified | Z-1659-2008 | Nonconforming Material/Component | LifeSync Wireless ECG System - Intermittent failure when using LS-202 and LS-232 LeadWear in conjunction with LS-41245 and LS-41285 Adaptors. The out of box failure manifests as a V-Lead failure, leading to a possible delay in treatment… |
| Dec 13, 2007 | Not classified | Z-1660-2008 | Nonconforming Material/Component | LifeSync Wireless ECG System - Intermittent failure when using LS-202 and LS-232 LeadWear in conjunction with LS-41245 and LS-41285 Adaptors. The out of box failure manifests as a V-Lead failure, intended for use as a radiofrequency… |
| Jan 10, 2007 | Not classified | Z-0546-2007 | Other | When the V-lead is separated from the rest of the lead set, the laminate may tear, exposing the dielectric layer causing a break in the silver ink. If the product is used during a defibrillation after such a de-lamination, it could burn… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 8.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K061993 (Hidalgo Limited, 2006) has gone furthest, with 99 descendants of its own.
- 6 other devices also cite its predicate K974149.
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.
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 GMPlWireless Medicine LifeSyncTMSystem is indicated for use when ECG monitoring is needed and a wireless cable-free connection is desired between the patient and the ECG Monitor. The LifeSyncTMSystem will also transmit the patient respiration waveform for those ECG systems that include a respiration function.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030795 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030795: Lifesyne Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030795
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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