# K181352: Loop System

- Pathway: 510(k) (Traditional)
- Applicant: Spry Health, Inc.
- Decided: Mar 29, 2019 after 311 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K962603 (1997). 111 ancestors in all.
10 later devices descend from it; 4 cite it directly.
1 of 122 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181956: Masimo MightySat Rx Fingertip Pulse Oximeter, Masimo Corporation (2019). Cleared while this submission was under review Summary page 4.

## Most influential descendants
- K221282: Empatica Health Monitoring Platform (2022), 7 descendants of its own
- K230457: Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal (2023), 4 descendants of its own
- K252981: EmbraceMini (2025), 1 descendant of its own
- K232915: EpiMonitor (2024), 1 descendant of its own
- K260374: Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal (2026), 0 descendants of its own

## Indications for use
The Loop System is intended for adult patients in the home environment for passive, non-invasive, intermittent data collection of physiological parameters that will later be transmitted to a web server for remote review by a clinician. The Loop System measures and records: • arterial oxygen saturation (SpO2) • heart rate (HR) • respiration rate (RR) All of these measurements are made when no motion is detected by the System. The Loop System device does not provide physiological alarms

Source page: https://510kreport.com/device/K181352
Methodology: https://510kreport.com/methodology