# K000794: Modification to MARSPO2, Model 2001

- Pathway: 510(k) (Special)
- Applicant: Novametrix Medical Systems, Inc.
- Decided: Apr 10, 2000 after 28 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
248 later devices descend from it; 2 cite it directly.
0 of 249 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
- K030886: Nico with Mars, Model 7300 (2003), 246 descendants of its own
- K053522: Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00 (2006), 233 descendants of its own
- K060221: The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient Monitors (2006), 222 descendants of its own
- K060541: The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient Monitors (2006), 221 descendants of its own
- K061052: The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90 (2006), 211 descendants of its own

## Recalls of this device
- Nov 19, 2009 · Not classified · Z-1304-2010: Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defecti
- Nov 19, 2009 · Not classified · Z-1303-2010: Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defecti
- Nov 19, 2009 · Not classified · Z-1308-2010: Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defecti
- Nov 19, 2009 · Not classified · Z-1302-2010: Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defecti
- Sep 2, 2002 · Not classified · Z-1049-04: Audio alarm may fail to sound when SpO2 limits drop below the set limits

Source page: https://510kreport.com/device/K000794
Methodology: https://510kreport.com/methodology