# K123658: Biomodule 3-M1

- Pathway: 510(k) (Traditional)
- Applicant: Zephyr Technology Corporation
- Decided: Apr 24, 2013 after 147 days
- Product code: DRX (Electrode, Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K130415: High Metabolite Qualicheck, Radiometer Medical Aps (2013). Our reading of the summary gave K130415, FDA’s number for High Metabolite Qualicheck (Radiometer Medical Aps). Its FDA name has none of the distinctive words the summary uses for the device it names, “Zephyr Technology BioHarness 3.0”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K181165: Philips wearable biosensor-G5 Solution (2019), 1 descendant of its own
- K163694: Rooti Rx ECG Event Recorder, Rooti Link APP Software (2017), 1 descendant of its own
- K213233: EZYPRO ECG Recorder (Model: UG02) (2022), 0 descendants of its own
- K192875: Philips Biosensor BX100 (2020), 0 descendants of its own

## Indications for use
The BioModule 3-MI is a physiological monitoring telemetry device intended for monitoring ambulatory patients in alternate care settings. The device consists of adhesive electrodes and an electronics module. The device stores and transmits vital sign data including ECG, heart rate, respiration rate, body orientation and activity. The BioModule 3-MI provides a facility to detect and transmit single lead ECG signals to be received by qualified instruments. The BioModule 3-MI collects and transmits measurements captured in alternate care settings as prescribed by the health care professional. Breathing rate values are accurately transmitted only during sedentary periods. The BioModule 3-MI is indicated for use as a general patient monitor to provide physiological information as part of general ward monitoring system.

Source page: https://510kreport.com/device/K123658
Methodology: https://510kreport.com/methodology