# K101568: Model SB100II Finger Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Atlantean
- Decided: Sep 20, 2010 after 110 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: 5 generations back to K001085 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082641: Fingertip Pulse Oximeter, Models CMS-50D, CMS-50L, CMS-50DL, Contec Medical System Co., Ltd. (2008)

## Cited in the summary but kept off the family tree
- K091317: Lumbofix Conductive Garment, Model 420 Back, Bio-Medical Research, Ltd. (2009). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The SB10011 Fingertip Pulse Oximeter is a non-invasive device intended for the spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult and pediatric patients in home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care etc.). The SB10011 is not intended for continuous monitoring.

Source page: https://510kreport.com/device/K101568
Methodology: https://510kreport.com/methodology