# K982728: Nellcor Puritan Bennett Uniprobe Adapter Cable, UP12A, UP12B, UP12C

- Pathway: 510(k) (Traditional)
- Applicant: Nellcor Puritan Bennett, Inc.
- Decided: Dec 7, 1998 after 124 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
Longest line of descent: 1 generation back to K850494 (1985). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K850494: Ohmeda Biox 3700 Pulse Oximeter, Ohmeda Medical (1985) Summary page 1.
- K872772: Ohmeda Biox 3740 Pulse Oximeter, Ohmeda Medical (1987) Summary page 1.
- K874104: Ohmeda Biox 3760 Pulse Oximeter, Ohmeda Medical (1987) Summary page 1.
- K962127: Ohmeda 3800 Pulse Oximeter, Ohmeda Medical (1996) Summary page 1.
- K921669: Marquette SL Series Transport Remote Acquisition, Marquette Electronics, Inc. (1993) Summary page 1.

## Indications for use
The UniProbe Adapter Cable allows specified Nellcor brand reusable and patient-dedicated oxygen sensors to be used with specified Ohmeda and Ohmeda-compatible Marquette Tram pulse oximetry monitors, to provide noninvasive measurement of oxygen saturation and pulse rate, The intended patient population for the UniProbe Adapter Cable includes adult, pediatric and neonatal patients, Use with any particular patient requires selection of an appropriate Nellcor brand oxygen sensor. The UniProbe Adapter Cable may be used in any hospital or hospital-type environment where the specified compatible monitors may be used. The UniProbe is contraindicated for use during MRI scanning. The UniProbe Adapter Cable is NOT intended for use in the home care environment. The UniProbe Adapter Cable is a prescription device and is to be used by qualified health care professionals only,

Source page: https://510kreport.com/device/K982728
Methodology: https://510kreport.com/methodology