510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K033973Substantially Equivalent

Oxisensor II Recycled Sensor and Oximax Recycled Sensor

Medtronic, Inc., Pleasanton CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K033973 is the FDA 510(k) clearance record for OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR, a class II device, cleared for Nellcor Puritan Bennett, Inc. on under FDA product code NLF (Oximeter, Reprocessed). FDA's definition for product code NLF reads: "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)". FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K033973.

Clearance record

Decision date
Received
(357 days to decision)
Product code
NLF Oximeter, Reprocessed
Regulation
21 CFR 870.2700
Device class
Class II
Review panel
Cardiovascular
Applicant
Nellcor Puritan Bennett, Inc. 4280 Hacienda Dr., Pleasanton CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NLF

Trailing 12 months

FDA records hold no clearances under product code NLF in the trailing twelve months.

FDA records show no clearances under product code NLF in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NLF, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260