# K191574: OxSAT 100

- Pathway: 510(k) (Traditional)
- Applicant: S.L.P., Ltd.
- Decided: Apr 9, 2020 after 300 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: 7 generations back to K910772 (1991). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043359: 4100 Patient Oximeter Module, Nonin Medical, Inc. (2005) Summary page 4.

## Indications for use
The SLP OxSAT 100 Patient Oximeter Module is indicated for use in measuring and transmitting functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and plethysmographic data to a compatible PSG and/or HST device. It is not intended for use with low perfused patients.

Source page: https://510kreport.com/device/K191574
Methodology: https://510kreport.com/methodology