# K981655: Spacelabs Medical Disposable SP02 Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Spacelabs Medical, Inc.
- Decided: Dec 3, 1999 after 571 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 K893643 (1989). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915699: Nellcor Portable Pulse Oximeter Model N-20, Nellcor, Inc. (1993) Summary page 1.
- K893643: Novametrix MDLS 500A, 505A, 515A, & 7000A Oximeter, Novametrix Medical Systems, Inc. (1989) Summary page 1.
- K962127: Ohmeda 3800 Pulse Oximeter, Ohmeda Medical (1996) Summary page 1.

## Indications for use
An accessory to an SpO2 monitoring system for use in noninvasive, continuous monitoring of oxygen saturation for the detection of dessturation due to abnormal puimonary/circulatory function in adult, pediatric or infant population by the standard photoelectric pulse of oximetric technique. Sensors are available for common monitoring sites, including the fingertip and foot.

Source page: https://510kreport.com/device/K981655
Methodology: https://510kreport.com/methodology