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

FDA 510(k) K191018 · Surgical Instrument Service and Savings, Inc.

Substantially Equivalent

510(k) numberK191018

Submission

Device name
Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors
Applicant
Surgical Instrument Service and Savings, Inc.
Redmond, OR, US
Received
April 17, 2019
Decision date
July 3, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NLF – Oximeter, Reprocessed
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2700
Specialty
Cardiovascular

same as DQA except reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

Other 510(k)s with product code NLF

510(k)DeviceApplicantDecision
K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…NLF · Traditional Stryker Sustainability Solutions10/22/2024SE
K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…NLF · Traditional Stryker Sustainability Solutions12/04/2022SE
K211138Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L)…NLF · Traditional Stryker Sustainability Solutions03/08/2022SE
K201699Medline ReNewal Reprocessed Nellcor OxiMax SpO2 SensorNLF · Special Surgical Instrument and Savings Inc (Dba Medline…07/22/2020SE
K111773Renu Medical Reprocessed Oximax Sensors: Adult, Pediatric, Infant and NeonateNLF · Traditional Renu Medical, Inc.11/16/2011SE
K110723M-Lncs Oximetry Sensors, Reprocessed M-Lncs Oximetry SensorsNLF · Special Masimo Corporation07/28/2011SE
K102560Reprocessed Pulse Oximeter SensorsNLF · Traditional Sterilmed, Inc.02/18/2011SE
K101280Midwestern Reprocessing Center Reprocessed Pulse Oximeter ProbeNLF · Traditional Midwest Reprocessing Center, LLC10/07/2010SE
K092368Reprocessed Pulse Oximeter SensorsNLF · Traditional Sterilmed, Inc.11/03/2009SE
K083719LNCS Oximetry SensorsNLF · Traditional Masimo Corporation07/30/2009SE

More from Masimo Corporation

510(k)DeviceDecision
K250314Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerPNE · Traditional 12/19/2025SE
K252405Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable…NLH · Traditional 11/26/2025SE
K250772Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable…NLH · Traditional 07/11/2025SE
K250545Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound…OWQ · Traditional 06/05/2025SE
K243101Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens…OWQ · Traditional 03/10/2025SE
K242225Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic CatheterNLH · Traditional 11/29/2024SE
K241156Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter…NLH · Traditional 09/14/2024SE
K234064Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens…OWQ · Traditional 09/10/2024SE
K240972Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)NLH · Traditional 06/07/2024SE
K232511Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)NUJ · Traditional 04/29/2024SE

Questions and answers

When was Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors cleared by the FDA?

Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors (K191018) received a 510(k) decision of Substantially Equivalent on July 3, 2019, 77 days after the submission was received.

What is the product code of K191018?

The FDA product code is NLF – Oximeter, Reprocessed, a Class II (moderate risk) device regulated under 21 CFR 870.2700.