# K983684: Datex-Ohmeda 3800+/3800P+ or 3900/3900P Pulse Oximeters

- Pathway: 510(k) (Special)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Nov 6, 1998 after 17 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
No predicates in its family tree.
46 later devices descend from it; 6 cite it directly.
4 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Datex-Ohmeda 3800 Pulse Oximeter: named in the summary without a submission number

## Most influential descendants
- K021955: Trutrak Plus Enhancements to the Datex-Ohmeda 3800 Series & 3900 Series Oximeters & Accessories (2002), 28 descendants of its own
- 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

## Indications for use
The Datex-Chmeda 3900/3900P Pulse Oximeters measure arterial oxygen saturation and pulse rate noninvasively using Datex-Ohmeda disposable and reusable finger and ear Sensors. Additionally, the Datex-Ohmeda 3900/3300P Pulse Oximeters measure Relative Perfusion Index™ pulsatile value, which is an indicator of relative perfusion at the sensor sife. US federal and Canadian laws restrict the sale of this device by or on the order of a licensed medical practitioner.

Source page: https://510kreport.com/device/K983684
Methodology: https://510kreport.com/methodology