# K181738: Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Instrument Service and Savings Inc (Dba Medline
- Decided: Mar 22, 2019 after 263 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: 7 generations back to K962603 (1997). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052186: Nellcor Oximax Pulse Oximetry Sensons (Max-a, Max-AL, Max-N, Max-I, Max-P, Nellcor Puritan Bennett, Inc. (2005) Summary page 4.

## Most influential descendants
- K201699: Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor (2020), 0 descendants of its own

## Indications for use
The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensors models MAXA, MAXAL, MAXP, and MAXI are indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients in the sizes indicated in the respective sensor directions for use. These devices are for prescription use only.

Source page: https://510kreport.com/device/K181738
Methodology: https://510kreport.com/methodology