# K032509: Mark 5 Nuvo (M5C5)

- Pathway: 510(k) (Traditional)
- Applicant: Nidek Medical Products, Inc.
- Decided: Mar 18, 2004 after 217 days
- Product code: CAW (Generator, Oxygen, Portable)
- Device class: 2
- Regulation: 21 CFR 868.5440
- Recalls of this device: 7 (7 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K883591 (1988). 2 ancestors in all.
12 later devices descend from it; 3 cite it directly.
2 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K883591: Mark-5 Concentrator, Nidek Medical Products, Inc. (1988) Summary page 1.
- K895141: Model 590 Oxygen Concentrator, Puritan Bennett Corp. (1989) Summary page 1.

## Most influential descendants
- 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
- K040892: Mark 5 Nuvo Ocsi (M5C5), Models 505 and 905 (2004), 2 descendants of its own

## Recalls of this device
- May 1, 2012 · Class I · Z-1775-2012: Capacitor failure may result in a fire hazard and loss of supplemental oxygen.
- May 1, 2012 · Class I · Z-1780-2012: Capacitor failure may result in a fire hazard and loss of supplemental oxygen.
- May 1, 2012 · Class I · Z-1782-2012: Capacitor failure may result in a fire hazard and loss of supplemental oxygen.
- May 1, 2012 · Class I · Z-1781-2012: Capacitor failure may result in a fire hazard and loss of supplemental oxygen.
- May 1, 2012 · Class I · Z-1774-2012: Capacitor failure may result in a fire hazard and loss of supplemental oxygen.
- May 1, 2012 · Class I · Z-1777-2012: Capacitor failure may result in a fire hazard and loss of supplemental oxygen.
- May 1, 2012 · Class I · Z-1779-2012: Capacitor failure may result in a fire hazard and loss of supplemental oxygen.

## Indications for use
The Mark 5 Nuvo (M5C5) Oxygen Concentrator is 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/K032509
Methodology: https://510kreport.com/methodology