# K974149: Ambulatory X-12 Telemetry Module

- Pathway: 510(k) (Traditional)
- Applicant: Mortara Instrument, Inc.
- Decided: Jan 8, 1998 after 65 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K891104 (1989). 2 ancestors in all.
122 later devices descend from it; 7 cite it directly.
0 of 125 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920429: Modified Model M1403A Telemetry Monitoring System, Hewlett-Packard Co. (1993) Summary page 3.
- K891104: CD Telemetry Systems, Marquette Electronics, Inc. (1989) Summary page 3.

## Most influential descendants
- K030795: Lifesyne Systems (2003), 109 descendants of its own
- 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

## Recalls of this device
- Mar 18, 2020 · Class II · Z-1814-2020: Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.

## Indications for use
The device is intended to be used as a radiofrequency physiological signal transmitter and receiver to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another. The received signal is reconditioned by the device into its original format so that it can be displayed.

Source page: https://510kreport.com/device/K974149
Methodology: https://510kreport.com/methodology