# K231531: Pediarity™

- Pathway: 510(k) (Traditional)
- Applicant: Hinlab, Inc.
- Decided: Dec 21, 2023 after 209 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: 24 generations back to K962603 (1997). 96 ancestors in all.
No later device cites it as a predicate yet.
2 of 97 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201770: Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor, Masimo Corporation (2020) Summary page 5.

## Indications for use
The Pediarityᵀᴹ system is intended for use in the home setting for spot-checking and/or continuous recording of pulse rate (PR) and functional oxygen saturation of arterial hemoglobin (SpO2) of well-perfused infants and children in non-motion conditions. The Pediarityᵀᴹ system is not a monitoring device and does not provide physiological alarms during use. Measurements are sent to a web server for remote review by a physician.

Source page: https://510kreport.com/device/K231531
Methodology: https://510kreport.com/methodology