# K982331: Keller Pulse Oximeter, Model 850+

- Pathway: 510(k) (Traditional)
- Applicant: Keller Medical Specialties Products, Inc.
- Decided: Sep 11, 1998 after 71 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 K895987 (1990). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895987: Keller Pulse Oximeter - KMS 850, Keller Medical Specialties Products, Inc. (1990) Summary page 1.

## Most influential descendants
- K990648: Keller Vital Signs Monitor, KMS 890+ (1999), 0 descendants of its own

## Indications for use
The Keller Medical Specialties Pulse Oximeter Model 850+ measures and monitors arterial oxygen saturation (Sa02) and pulse rate using standard dual wavelength pulse oximetry techniques. This unit is portable with battery operation. The oximeter allows complete control of patient alarm limit settings. This unit is not intended for use on neonates.

Source page: https://510kreport.com/device/K982331
Methodology: https://510kreport.com/methodology