# K052693: PM-50 Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Mar 30, 2006 after 183 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 K001688 (2000). 1 ancestor in all.
13 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001688: Datex-Ohmeda Tuffsat 3000 Pulse Oximeter, Datex-Ohmeda, Inc. (2000) Summary page 1.

## Most influential descendants
- K061442: Pulse Oximeter, Model PM-50 (2006), 8 descendants of its own
- K072235: PM-50 Pulse Oximeter and VS-800 Vital Signs Monitor (2007), 7 descendants of its own
- K172792: Handheld Pulse Oximeter, Model SP-20 (2018), 3 descendants of its own
- K132037: Vital Signs Monitor (2014), 3 descendants of its own
- K201468: Pulse Oximeter (2021), 2 descendants of its own

## Indications for use
The PM-50 Pulse Oximeter is a non-invasive, spot-check, oxygen saturation and pulse rate monitor. It operates only on battery power using existing PM-50 sensors labeled for patients ranging from neonates to adults.

Source page: https://510kreport.com/device/K052693
Methodology: https://510kreport.com/methodology