# K132516: Oxiprobe E (Oxiprobe)

- Pathway: 510(k) (Traditional)
- Applicant: Bio Medical Technologies Co., Ltd.
- Decided: Jul 30, 2014 after 352 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: 11 generations back to K941811 (1994). 49 ancestors in all.
No later device cites it as a predicate yet.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092549: Oxiprobe, Models BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P, Bio Medical Technologies Co., Ltd. (2009) Summary page 1.

## Indications for use
The OxiprobE is indicated for non-invasive, continuous, beat-by-beat monitoring of oxygen saturation of functional arterial hemoglobin, pulse rate, and pulse amplitude. Individual models are labeled for the intended use. It is for prescription use only.

Source page: https://510kreport.com/device/K132516
Methodology: https://510kreport.com/methodology