# K962127: Ohmeda 3800 Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Ohmeda Medical
- Decided: Oct 10, 1996 after 129 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.
42 later devices descend from it; 7 cite it directly.
4 of 43 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) Ohmeda 3760 Pulse Oximeter: named in the summary without a submission number
- (no number) Ohmeda Handheld 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 Ohmeda Model 3800 Pulse Oximeter is a noninvasive, arterial oxygen saturation and pulse rate monitor.

Source page: https://510kreport.com/device/K962127
Methodology: https://510kreport.com/methodology