# K220351: Polso Watch

- Pathway: 510(k) (Traditional)
- Applicant: Chronisense Medical, Ltd.
- Decided: Nov 18, 2022 after 284 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: 21 generations back to K962603 (1997). 112 ancestors in all.
No later device cites it as a predicate yet.
1 of 113 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181352: Loop System, Spry Health, Inc. (2019) Summary page 4.

## Indications for use
The PolsoTM Watch is a wrist-worn device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2), pulse rate, and respiration rate. The PolsoTM Watch is a prescription-use device intended for spot-checking measurements of patients aged 18 years and older in the home use environment in non-motion conditions. The device is not intended to be used for diagnostic applications nor is it intended to independently guide treatment decisions. The device is not an apnea monitor. Physiological parameters will later be provided for remote review by a clinician.

Source page: https://510kreport.com/device/K220351
Methodology: https://510kreport.com/methodology