# K123738: Mark 5 Nuvo Lite Ocsi, Mark 5 Nuvo Lite STD

- Pathway: 510(k) (Special)
- Applicant: Nidek Medical Products, Inc.
- Decided: Feb 28, 2013 after 85 days
- Product code: CAW (Generator, Oxygen, Portable)
- Device class: 2
- Regulation: 21 CFR 868.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K883591 (1988). 7 ancestors in all.
No later device cites it as a predicate yet.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082566: Mark 5 Nuvo Lite Ocsi and STD, Nidek Medical Products, Inc. (2008) Summary page 1.

## Indications for use
The modified devices are intended solely for medical use in oxygen therapy programs under the supervision of a physician. This device is available by prescription only and is not intended to support or sustain life.

Source page: https://510kreport.com/device/K123738
Methodology: https://510kreport.com/methodology