# K021955: Trutrak Plus Enhancements to the Datex-Ohmeda 3800 Series & 3900 Series Oximeters & Accessories

- Pathway: 510(k) (Special)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Oct 8, 2002 after 116 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K010463 (2001). 4 ancestors in all.
28 later devices descend from it; 2 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)
- K962127: Ohmeda 3800 Pulse Oximeter, Ohmeda Medical (1996)
- K983684: Datex-Ohmeda 3800+/3800P+ or 3900/3900P Pulse Oximeters, Datex-Ohmeda, Inc. (1998) Summary page 1.
- K011670: Datex-Ohmeda Oxygen Saturation Module, M-Osat and Accessories (with Trutrak+Motion Correction Performance, Datex-Ohmeda (2001)

## Most influential descendants
- K040831: Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500 (2004), 27 descendants of its own
- 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

## Recalls of this device
- May 19, 2023 · Class I · Z-2034-2023: 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-2033-2023: There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.

## Indications for use
The Datex-Ohmeda 3800 Series and 3900 Series Oximeters with TruTrak Plus are indicated for spot-checking and continuous monitoring of functional oxygen saturation and pulse rate, including monitoring during conditions of clinical patient motion. 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/K021955
Methodology: https://510kreport.com/methodology