# K092549: Oxiprobe, Models BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P

- Pathway: 510(k) (Traditional)
- Applicant: Bio Medical Technologies Co., Ltd.
- Decided: Nov 16, 2009 after 89 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: 10 generations back to K941811 (1994). 48 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993637: N-395 Pulse Oximeter, with Extended Device Claims, Nellcor Puritan Bennett, Inc. (1999) Summary page 1.
- K063783: Philips Reusable SPO2 Sensors M1191T, M1192T and M1193T, Clip Sensor M1196T and Disposable SPO2 Sensors M1131A, M1132A, Philips Medical Systems, Inc. (2007) Summary page 1.

## Most influential descendants
- K132516: Oxiprobe E (Oxiprobe) (2014), 0 descendants of its own

## Indications for use
The OxiprobE is indicated for non-invasive, continuus, beat-by-beat monitoring of oxygen saturation of functional arterial hemoglobin, pulse rate and pulse amplitude. Individual models are labeled specifically for either adult or pediatric use. It is for jirescription use only.

Source page: https://510kreport.com/device/K092549
Methodology: https://510kreport.com/methodology