# K191018: Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Instrument Service and Savings, Inc.
- Decided: Jul 3, 2019 after 77 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: 16 generations back to K941811 (1994). 67 ancestors in all.
No later device cites it as a predicate yet.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101896: Masimo LNCS/M-LNCS Oximetry Sensors, Masimo Corporation (2010) Summary page 5.

## Indications for use
The Medline ReNewal Reprocessed Masimo LNCS Adult and Pediatric SpO2 Adhesive Sensors are indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult and pediatric patients during no motion conditions, and for patients who are well perfused in hospitals and hospital-type facilities.

Source page: https://510kreport.com/device/K191018
Methodology: https://510kreport.com/methodology