# K012622: Clearmedical/Nellcor Oxisensor II, Pediatric, Model D-20

- 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™ Pediatric O, Part D-20: named in the summary without a submission number

## Indications for use
The pediatric Oxisensor, model D-20, is indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing between 10 and 50 kg.

Source page: https://510kreport.com/device/K012622
Methodology: https://510kreport.com/methodology