# K012609: Clearmedical/Nellcor Oxisensor II, Neonatal/Adult, Model N-25

- Pathway: 510(k) (Traditional)
- Applicant: Clearmedical, Inc.
- Decided: Jul 3, 2002 after 324 days
- Product code: NLF (Oximeter, Reprocessed)
- 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Nellcor Oxisensor II Neonatal/Adult O₂, Part N-25: named in the summary without a submission number

## Indications for use
The neonatal/adult Oxisensor, model N-25, is Indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing less than 3 kg or more than 40 kg.

Source page: https://510kreport.com/device/K012609
Methodology: https://510kreport.com/methodology