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510(k) K083719

LNCS OXIMETRY SENSORS by Masimo Corporation — Product Code NLF

K083719 is an FDA 510(k) premarket notification submitted by Masimo Corporation for the device "LNCS OXIMETRY SENSORS". The FDA issued a decision of Substantially Equivalent on July 30, 2009. The device falls under product code NLF (Oximeter, Reprocessed), a Class II device regulated under 21 CFR 870.2700. Masimo Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2009
Date Received
December 15, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter, Reprocessed
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
Submission Type

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 clearances by Masimo Corporation

  • K260880 — SedLine Sedation Monitor (July 10, 2026)
  • K254209 — Radius VSM and Accessories (June 4, 2026)
  • K243324 — Masimo O3 Regional Oximeter (July 17, 2025)
  • K250757 — Radius VSM and Accessories (May 29, 2025)
  • K243305 — Masimo W1 (April 3, 2025)
  • K240229 — Masimo W1 (August 8, 2024)
  • K234021 — Masimo Stork (May 3, 2024)
  • K214115 — MightySat -OTC (January 31, 2024)
  • K223721 — Masimo Stork (December 15, 2023)
  • K232512 — Masimo W1 (November 17, 2023)

Other clearances for product code NLF

  • K241758 — Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pul (October 22, 2024)
  • K222019 — Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Puls (December 4, 2022)
  • K211138 — Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-2 (March 8, 2022)
  • K201699 — Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor (July 22, 2020)
  • K191018 — Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive (July 3, 2019)
  • K111773 — RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE (November 16, 2011)
  • K110723 — M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS (July 28, 2011)
  • K102560 — REPROCESSED PULSE OXIMETER SENSORS (February 18, 2011)
  • K101280 — MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE (October 7, 2010)
  • K092368 — REPROCESSED PULSE OXIMETER SENSORS (November 3, 2009)

FDA data resources