# K072581: PM-60 Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Jan 8, 2008 after 117 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: 13 generations back to K941811 (1994). 102 ancestors in all.
19 later devices descend from it; 4 cite it directly.
0 of 122 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070791: PM Series Patient Monitors, Models PM-9000 Express and PM-8000 Express, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2007) Summary page 1.
- K051352: Oximax NPB-40 Handheld Pulse Oximeter, Nellcor Puritan Bennett, Inc. (2005) Summary page 2.

## Most influential descendants
- K090599: MD300K1 Pulse Oximeter (2009), 9 descendants of its own
- K152563: Pulse Oximeter (MD300M/MD300K2) (2016), 8 descendants of its own
- K162199: Cascade IOMAX Intraoperative Monitor (2017), 7 descendants of its own
- K212166: ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (2022), 5 descendants of its own
- K090671: Pulse Oximeter, Models CMS50E, CMS50F, CMS60C, CMS60D (2009), 3 descendants of its own

## Indications for use
The PM-60 handheld Pulse Oximeter is intended for continuous monitoring, spot-checking of functional pulse oxygen saturation (SpO 2) and pulse rate (PR) of single adult, pediatric and neonatal patients in hospitals, out-of-hospital transport and home care.

Source page: https://510kreport.com/device/K072581
Methodology: https://510kreport.com/methodology