# K082566: Mark 5 Nuvo Lite Ocsi and STD

- Pathway: 510(k) (Abbreviated)
- Applicant: Nidek Medical Products, Inc.
- Decided: Dec 3, 2008 after 90 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: 3 generations back to K883591 (1988). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040892: Mark 5 Nuvo Ocsi (M5C5), Models 505 and 905, Nidek Medical Products, Inc. (2004) Summary page 1.
- K032509: Mark 5 Nuvo (M5C5), Nidek Medical Products, Inc. (2004) Summary page 1.
- K061261: L4 Oxygen Concentrator, Respironics, Inc. (2006) Summary page 1.

## Most influential descendants
- K123738: Mark 5 Nuvo Lite Ocsi, Mark 5 Nuvo Lite STD (2013), 0 descendants of its own

## Indications for use
The proposed 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/K082566
Methodology: https://510kreport.com/methodology