# K952315: Satmaster, Computerized Pulse Oximetry Software

- Pathway: 510(k) (Traditional)
- Applicant: Emg Scientific
- Decided: Dec 4, 1996 after 567 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: 1 generation back to K863784 (1986). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K863784: Nellcor N-200 (Pulse Oximeter), Nellcor, Inc. (1986) Summary page 2.
- K901399: Powerbase II (PB2), Nellcor, Inc. (1990) Summary page 2.

## Indications for use
SatMaster is intended for use as an adjunct to traditional Pulse Oximetry, in which the caregiver observes instantaneous Pulse Oximetry values as displayed on a Pulse Oximeter’s face. SatMaster produces graphs and statistics describing a patient’s Pulse Oximetry data trends over relatively long periods of time, including those times when the caregiver is not directly observing the Pulse Oximeter’s display. In a hospital setting, SatMaster would be used in association with ICU’s, Operating and Recovery Rooms, Pulmonary Function Labs, Sleep Labs, and research. In home-care settings, SatMaster would be used for sleep studies and home-oxygen evaluations. It is expected that the Pulse Oximeter itself will be operated by competent personnel in accordance with the Pulse Oximeter manufacturer’s FDA-approved instructions.

Source page: https://510kreport.com/device/K952315
Methodology: https://510kreport.com/methodology