# K222597: BabySat 3

- Pathway: 510(k) (Traditional)
- Applicant: Owlet Babycare, Inc.
- Decided: Jun 16, 2023 after 291 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: 8 generations back to K910772 (1991). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182822: Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System, Taiwan Aulisa Medical Devices Technologies, Inc. (2019). Our reading of the summary gave K182882, FDA’s number for CrystalView Pro Irrigation Console, CrystalView Pro… (Conmed Corporation). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System”. Summary page 6.

## Indications for use
The BabySat 3 pulse oximeter is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse rate. It is indicated for spot-checking and/or continuous monitoring of well-perfused patients greater than one month old up to 18 months old and weighing between 6 and 30 lbs., in the home environment

Source page: https://510kreport.com/device/K222597
Methodology: https://510kreport.com/methodology