# K260157: LifeLens Physiological Monitor

- Pathway: 510(k) (Traditional)
- Applicant: LifeLens Technologies, Inc.
- Decided: Jul 9, 2026 after 170 days
- Product code: DSH (Recorder, Magnetic Tape, Medical)
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 22 generations back to K962603 (1997). 177 ancestors in all.
No later device cites it as a predicate yet.
1 of 178 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203168: LifeLens Wireless ECG Monitor, LifeLens Technologies, Inc. (2021) Summary page 5.
- K242018: UbiqVue™ 2A Multi-parameter System (UX2550), Lifesignals, Inc. (2024) Summary page 5.

## Indications for use
The LifeLens Physiological Monitor is intended for spot-check monitoring and continuous data storage of physiological data in home and healthcare settings. Data could include ECG, oxygen saturation of arterial hemoglobin (SpO2), heart rate (HR), heart rate variability (HRV), skin temperature (TEMP), respiration rate (RR). Data are securely transmitted from the device for storage, review, analysis, and display. Data from the device are intended as an aid to diagnosis, disease management, and treatment. The device is intended for use on adults (18 years of age or older). The LifeLens Physiological Monitor also reports wellness data including activity level, body position, step count, and gait analysis.

Source page: https://510kreport.com/device/K260157
Methodology: https://510kreport.com/methodology