# K991823: N-395 Pulse Oximeter, Model N-395

- Pathway: 510(k) (Traditional)
- Applicant: Nellcor Puritan Bennett, Inc.
- Decided: Aug 25, 1999 after 89 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: 3 generations back to K962603 (1997). 4 ancestors in all.
785 later devices descend from it; 21 cite it directly.
6 of 790 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955642: Nellcor Symphony N-3000 Patient Monitor W/SP02 & Ecg/N-3200 Display/Printer, Nellcor Puritan Bennett, Inc. (1996) Summary page 1.
- K982255: Model 2000 Pulse Oximeter, Ivy Biomedical Systems, Inc. (1998) Summary page 1.

## Most influential descendants
- 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
- K012451: Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 (2001), 280 descendants of its own
- K033048: Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS (2004), 272 descendants of its own

## Indications for use
The intended use of the N-395 Pulse Oximeter is the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO,) and pulse rate. For use with neonatal, pediatric and adult patients, in hospitals, hospital-type facilities and intra-hospital transport environments. For prescription use only.

Source page: https://510kreport.com/device/K991823
Methodology: https://510kreport.com/methodology