# K993637: N-395 Pulse Oximeter, with Extended Device Claims

- Pathway: 510(k) (Special)
- Applicant: Nellcor Puritan Bennett, Inc.
- Decided: Nov 24, 1999 after 27 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: 3 generations back to K962603 (1997). 4 ancestors in all.
715 later devices descend from it; 12 cite it directly.
3 of 720 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). Our OCR of the scanned summary read K882255, which is not a number in FDA’s lists. Corrected to the only number one digit away in this product code whose FDA name shares the summary’s words.

## 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

## Recalls of this device
- Oct 18, 2004 · Not classified · Z-0665-05: The internal speaker components are failing and do not produce an audio alarm in the event of patient emergency.

## Indications for use
The N-395 Pulse Oximeter is indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. For use with neonatal, pediatric and adult patients during both no motion and motion conditions and for patients who are well or poorly perfused, in hospitals, hospital-type facilities and intra-hospital transport environments. For prescription use only.

Source page: https://510kreport.com/device/K993637
Methodology: https://510kreport.com/methodology