# K040831: Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Sep 2, 2004 after 155 days
- Product code: DPZ (Oximeter, Ear)
- Device class: 2
- Regulation: 21 CFR 870.2710
- Recalls of this device: 5 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K010463 (2001). 5 ancestors in all.
27 later devices descend from it; 4 cite it directly.
4 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021955: Trutrak Plus Enhancements to the Datex-Ohmeda 3800 Series & 3900 Series Oximeters & Accessories, Datex-Ohmeda, Inc. (2002) Summary page 1.

## Most influential descendants
- K073203: Carescape V100 (2007), 20 descendants of its own
- K102426: Carescape Model V100 Vital Signs Monitor (2010), 11 descendants of its own
- K120598: Procare Monitor B40 (2012), 10 descendants of its own
- K130584: Monitor B40 (2013), 8 descendants of its own
- K133576: Monitor B40 (2014), 7 descendants of its own

## Recalls of this device
- May 19, 2023 · Class I · Z-2026-2023: There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
- May 19, 2023 · Class I · Z-2031-2023: There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
- May 19, 2023 · Class I · Z-2032-2023: There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
- Apr 8, 2011 · Not classified · Z-3206-2011: The plastic enclosure on the external power supply of the TruSat Pulse Oximeter is prone to breakage, and overheating. The issue may impact patient or user safety. Potential for system or components t
- Apr 29, 2010 · Not classified · Z-1814-2010: GE Healthcare has recently become aware that the TruSat Pulse Oximeter with external power supply does not comply with current safety standards. It is possible that the external power supply could lea

## Indications for use
The Datex-Ohmeda TruSat Pulse Oximeter and Accessories is indicated for spot-checking and continuous monitoring of functional oxygen saturation and pulse rate, including monitoring during conditions of clinical patient motion or low perfusion. These devices are intended for use with adult, pediatric and neonatal patients in both hospital and non-hospital environments.

Source page: https://510kreport.com/device/K040831
Methodology: https://510kreport.com/methodology