# K030795: Lifesyne Systems

- Pathway: 510(k) (Traditional)
- Applicant: Gmp/Companies, Inc.
- Decided: Aug 5, 2003 after 146 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K891104 (1989). 3 ancestors in all.
109 later devices descend from it; 4 cite it directly.
0 of 113 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974149: Ambulatory X-12 Telemetry Module, Mortara Instrument, Inc. (1998) Summary page 1.

## Most influential descendants
- K061993: Equivital, Model EQ-01 (2006), 99 descendants of its own
- K113054: Equivital (2012), 71 descendants of its own
- K141167: Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software Library and Secure Server Software Library) (2014), 70 descendants of its own
- K152139: Vital Connect Platform, HealthPatch MD, VitalPatch (2015), 43 descendants of its own
- K081140: Visensia (2008), 22 descendants of its own

## Recalls of this device
- Dec 13, 2007 · Not classified · Z-1659-2008: 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, lead
- Dec 13, 2007 · Not classified · Z-1660-2008: 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, inte
- Jan 10, 2007 · Not classified · Z-0546-2007: 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

## Indications for use
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.

Source page: https://510kreport.com/device/K030795
Methodology: https://510kreport.com/methodology