# K883591: Mark-5 Concentrator

- Pathway: 510(k) (Traditional)
- Applicant: Nidek Medical Products, Inc.
- Decided: Nov 2, 1988 after 71 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
No predicates in its family tree.
13 later devices descend from it; 1 cites it directly.
2 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K032509: Mark 5 Nuvo (M5C5) (2004), 12 descendants of its own
- K071608: A&J POCA01 Oxygen Concentrator (2008), 8 descendants of its own
- K080391: Drive Solstice Oxygen Concentrator (2008), 5 descendants of its own
- K090007: Jumao Oxygen Concentrator, Model JM-07000HI, JM-07000I, JM-07000 (2009), 4 descendants of its own
- K230969: Oxygen Concentrator (2023), 3 descendants of its own

Source page: https://510kreport.com/device/K883591
Methodology: https://510kreport.com/methodology