# K062149: SP02 Sensor FS and PS 'Silc-Touch' Series; SP02 Sensor FC, FP and Y Series

- Pathway: 510(k) (Traditional)
- Applicant: International Business Strategies
- Decided: May 31, 2007 after 308 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 K011518 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011518: Vitalsat Series, Beta Biomed Services, Inc. (2002) Summary page 2.

## Indications for use
IT Dr. Gambert's reusable medical SpO2 sensors, the FS and PS "silc touch" Series and FC, FP and Y Series, are intended to non-invasively measure the pulse frequency and functional oxygen saturation of arterial hemoglobin (SpO2) when used in conjunction with the BCI Advisor, Datex Ohmeda TuffSat, HP Philips M3, Nellcor NPB-40 and Novametrix 512 pulse oximeters. The sensors are to be used in accordance with the recommendations and specifications of the oximeter manufacturer.

Source page: https://510kreport.com/device/K062149
Methodology: https://510kreport.com/methodology