# K061442: Pulse Oximeter, Model PM-50

- Pathway: 510(k) (Special)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Sep 5, 2006 after 104 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: 2 generations back to K001688 (2000). 2 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052693: PM-50 Pulse Oximeter, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2006) Summary page 1.

## Most influential descendants
- K072235: PM-50 Pulse Oximeter and VS-800 Vital Signs Monitor (2007), 7 descendants of its own
- K132037: Vital Signs Monitor (2014), 3 descendants of its own
- K132038: Accutorr 7 Vital Signs Monitor (2014), 2 descendants of its own
- K202892: Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s (2021), 1 descendant of its own
- K170712: Accutorr 7/VS-900 Vital Signs Monitor (2017), 1 descendant 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 disposable and reusable sensors labeled for patients ranging from neonates to adults.

Source page: https://510kreport.com/device/K061442
Methodology: https://510kreport.com/methodology