# K201699: Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor

- Pathway: 510(k) (Special)
- Applicant: Surgical Instrument and Savings Inc (Dba Medline Renewal)
- Decided: Jul 22, 2020 after 30 days
- Product code: NLF (Oximeter, Reprocessed)
- 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: 8 generations back to K962603 (1997). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181738: Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors, Surgical Instrument Service and Savings Inc (Dba Medline (2019) Summary page 5.

## Indications for use
The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor Model MAXNAR is indicated for single patient use when continuous non-invasive arterial oxygen saturation and pulse rate monitoring is required for adult patients as indicated in the sensor directions for use. This device is for prescription use only.

Source page: https://510kreport.com/device/K201699
Methodology: https://510kreport.com/methodology