# K252984: Perin Health System (PHD80060-2)

- Pathway: 510(k) (Traditional)
- Applicant: Perin Health Devices, LLC
- Decided: Jan 22, 2026 after 126 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- 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). 169 ancestors in all.
No later device cites it as a predicate yet.
1 of 170 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242018: UbiqVue™ 2A Multi-parameter System (UX2550), Lifesignals, Inc. (2024) Summary page 6.
- K211365: Alio Medical Remote Monitoring System, Graftworx, Inc. Dba Alio (2022) Summary page 6.

## Indications for use
The Perin Health Platform is a wireless remote monitoring system intended for use by healthcare professionals for spot check collection of physiological data in healthcare and home settings for long-term monitoring. The Perin Health Patch can monitor auscultation data of heart and lung sounds, photoplethysmography waveforms (PPG), oxygen saturation (%SpO2), heart rate, electrocardiography (ECG), heart rate variability, R-R interval, respiratory rate, skin temperature, activity detection (including step count), and posture (body position relative to gravity including fall). The Perin Health System is intended for spot-checking and tracking changes of adult patients in hospitals, clinics, long-term care, and at home. In home-use environments, the Perin Health Platform is able to integrate with optional third-party devices for blood pressure, and weight data collection via the mobile application. The mobile application transmits data from the Health Patch and third party devices to the cloud and web-based portal for storage, analysis, and review by healthcare professionals. The Perin Health Platform can include the ability to notify healthcare professionals when physiological data falls outside set limits or manual trigger by the patient. The device is intended to provide physiological information for non-critical, adult population.

Source page: https://510kreport.com/device/K252984
Methodology: https://510kreport.com/methodology