# K982255: Model 2000 Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Ivy Biomedical Systems, Inc.
- Decided: Oct 22, 1998 after 118 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K962603 (1997). 2 ancestors in all.
816 later devices descend from it; 3 cite it directly.
6 of 819 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973887: Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables, Masimo Corp. (1998) Summary page 1.

## Most influential descendants
- K991823: N-395 Pulse Oximeter, Model N-395 (1999), 785 descendants of its own
- K993637: N-395 Pulse Oximeter, with Extended Device Claims (1999), 715 descendants of its own
- K012891: Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables (Aka Accessories) (2002), 548 descendants of its own
- K021090: Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter (2002), 426 descendants of its own
- K031740: VSM - Vital Signs Monitor, Model 53000 Series (2003), 290 descendants of its own

## Indications for use
Model 2000 Pulse Oximeter is indicated for the continuous noninvasive monitoring of arterial oxygen saturation (SpO₂) and pulse rates for adult, pediatric and neonatal patients in a hospital and mobile environment (within the hospital). In addition the Model 2000 is indicated for the continuous non-invasive monitoring of arterial oxygen saturation (SpO₂) and pulse rates for adults during patient motion conditions.

Source page: https://510kreport.com/device/K982255
Methodology: https://510kreport.com/methodology