# K993979: MARSPO2, Model 2001

- Pathway: 510(k) (Abbreviated)
- Applicant: Novametrix Medical Systems, Inc.
- Decided: Feb 22, 2000 after 90 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K962603 (1997). 6 ancestors in all.
255 later devices descend from it; 4 cite it directly.
0 of 262 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913516: Model 520A Novametrix Pulse Oximeter, Novametrix Medical Systems, Inc. (1991) Summary page 1.
- K982255: Model 2000 Pulse Oximeter, Ivy Biomedical Systems, Inc. (1998) Summary page 1.
- K991823: N-395 Pulse Oximeter, Model N-395, Nellcor Puritan Bennett, Inc. (1999) Summary page 1.

## 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
- Sep 2, 2002 · Not classified · Z-1049-04: Audio alarm may fail to sound when SpO2 limits drop below the set limits

## Indications for use
The Model 2001 Pulse Oximeter is intended to provide continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate units in neonatal, pediatric and adult patients in hospital, hospital-type facilities and intra-hospital transport environments such as the operating room, emergency department and intensive care units. The Model 2001 and its sensors are intended to be used by trained operators when pulse oximetry monitoring is required in the judgement of a physician.

Source page: https://510kreport.com/device/K993979
Methodology: https://510kreport.com/methodology