# K012891: Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables (Aka Accessories)

- Pathway: 510(k) (Traditional)
- Applicant: Nellcor Puritan Bennett, Inc.
- Decided: Mar 7, 2002 after 191 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). 8 ancestors in all.
548 later devices descend from it; 34 cite it directly.
2 of 557 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991823: N-395 Pulse Oximeter, Model N-395, Nellcor Puritan Bennett, Inc. (1999) Summary page 1.
- K993637: N-395 Pulse Oximeter, with Extended Device Claims, Nellcor Puritan Bennett, Inc. (1999) Summary page 1.
- K904039: Reflectance Sensor (RS-10), Nellcor, Inc. (1990) Summary page 1.
- K952222: Nellcor N-20PA Portable Pulse Oximeter, Nellcor, Inc. (1995) Summary page 1.

## Most influential descendants
- 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
- 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
- K050844: 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS, 750CM-3MS, 750C-3NL, 750CM-3NL (2005), 264 descendants of its own
- K060065: CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside Monitor (2006), 250 descendants of its own

## Recalls of this device
- Oct 18, 2004 · Not classified · Z-0664-05: The internal speaker components are failing and do not produce an audio alarm in the event of patient emergency.

## Indications for use
The OxiMAX Pulse Oximetry System with N-595 Pulse Oximeter and OxiMAX Sensors and Cables is indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The OxiMAX Pulse Oximetry System is intended for use with neonatal, pediatric, and adult patients during both no motion and motion conditions and for patients who are either well or poorly perfused, in hospitals, hospital-type facilities, intra-hospital transport, and home environments. These devices are for prescription use only. The Nellcor OxiMAX adult oxygen sensor, model MAX-A, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing more than 30 kg. The Nellcor OxiMAX adult oxygen sensor, model MAX-AL, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing more than 30 kg. The Nellcor OxiMAX pediatric oxygen sensor, model MAX-P, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing between 10 and 50 kg. The Nellcor OxiMAX infant oxygen sensor, model MAX-I, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing between 3 and 20 kg. The Nellcor OxiMAX neonatal/adult oxygen sensor, model MAX-N, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for neonates weighing less than 3 kg or adults weighing more than 40 kg. The Nellcor OxiMAX adult nasal oxygen sensor, model MAX-R, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing more than 50 kg. The Nellcor OxiMAX adhesive forehead reflectance sensor, model MAX-FAST, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing greater than 40 kg. The Nellcor OxiMAX OxiCliq adult oxygen sensor, model A, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing more than 30 kg. The OxiClig-A sensor is for use only with a Nellcor OxiCliq sensor cable, model OC-3. The Nellcor OxiMAX OxiCliq pediatric oxygen sensor, model P, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing between 10 and 50 kg. The OxiCliq-P sensor is for use only with a Nellcor OxiCliq sensor cable, model OC-3. The Nellcor OxiMAX OxiCliq infant oxygen sensor, model I, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing between 3 and 20 kg. The OxiClig-I sensor is for use only with a Nellcor OxiCliq sensor cable, model OC-3. The Nellcor OxiMAX OxiCliq neonatal/adult oxygen sensor, model N, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for neonates weighing less than 3 kg, or adults weighing more than 40 kg. The OxiClig-N sensor is for use only with a Nellcor OxiCliq sensor cable, model OC-3. The Nellcor OxiMAX Durasensor adult oxygen sensor, model DS-100A, is indicated for use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing greater than 40 kg. The Nellcor OxiMAX Dura-Y multisite oxygen sensor, model D-YS, is indicated for use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing greater than 1 kg. The Nellcor Dura-Y ear clip, model D-YSE, is intended for use only with the Nellcor OxiMAX Dura-Y oxygen sensor, model D-YS, when continuous, noninvasive arterial oxygen saturation and pulse rate monitoring are required. It is indicated for use for patients weighing 30 kg or more, using the ear lobe or pinna as a monitoring site. The Nellcor PediCheck pediatric spot-check clip, model D-YSPD, is intended for use only with the Nellcor OxiMAX Dura-Y oxygen sensor, model D-YS, when noninvasive, arterial oxygen saturation and pulse rate monitoring are required for patients weighing between 3 kg and 40 kg. The Nellcor OxiMAX Oxiband pediatric/infant oxygen sensor, model OXI-P/I, is indicated for use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing between 3 kg and 40 kg. The Nellcor OxiMAX Oxiband adult/neonatal oxygen sensor, model OXI-A/N, is indicated for use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing less than 3 kg or more than 40 kg. The Nellcor pulse oximetry cable, model DOC-10, is a 10-foot (3-meter) cable that links a Nellcor oxygen sensor to a compatible Nellcor pulse oximeter.

Source page: https://510kreport.com/device/K012891
Methodology: https://510kreport.com/methodology