# K082789: G1B Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: General Meditech, Inc.
- Decided: Jan 7, 2009 after 106 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: 4 generations back to K001085 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072825: Fingertip Pulse Oximeter, Model MD300I, Beijing Choice Electronic Technololgy Co., Ltd. (2008) Summary page 2.

## Indications for use
G1 B Pulse Oximeter is a portable non-invasive, spot-checking, oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patient at home, and hospital (including clinical use in internist/surgery, Anesthesia, intensive care and etc). Not for continuous monitoring.

Source page: https://510kreport.com/device/K082789
Methodology: https://510kreport.com/methodology