# K072235: PM-50 Pulse Oximeter and VS-800 Vital Signs Monitor

- Pathway: 510(k) (Special)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Oct 19, 2007 after 70 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K933143 (1994). 44 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061442: Pulse Oximeter, Model PM-50, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2006) Summary page 1.
- K063055: VS-800 Vital Signs Monitor, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2006) Summary page 1.

## Most influential descendants
- 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
- K233038: Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s (2024), 0 descendants of its own

## Recalls of this device
- Dec 31, 2009 · Not classified · Z-1397-2010: SmarTemp Disposable Probe covers may contain microscopic holes in the molded seam that would allow liquids or body fluids inside the cover and potentially contaminate the temperature probe.
- Dec 31, 2009 · Not classified · Z-1398-2010: SmarTemp Disposable Probe covers may contain microscopic holes in the molded seam that would allow liquids or body fluids inside the cover and potentially contaminate the temperature probe.

## 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. The VS-800 Vital Signs Monitor is used to monitor physiologic parameters including SpO2, PR and NIBP, and to measure Temperature parameter on adult, pediatric, and neonatal patients in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for transport or home use.

Source page: https://510kreport.com/device/K072235
Methodology: https://510kreport.com/methodology