510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081238Substantially Equivalent

Reprocessed Masimo Pulse Oximeter Sensors

Stryker Sustainability Solutions, Phoenix AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081238 is the FDA 510(k) clearance record for REPROCESSED MASIMO PULSE OXIMETER SENSORS, a class II device, cleared for Ascent Healthcare Solutions 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 88 510(k) clearances for Stryker Sustainability Solutions, from to . As of , FDA records show no recalls naming K081238.

Clearance record

Decision date
Received
(89 days to decision)
Product code
NLF Oximeter, Reprocessed
Regulation
21 CFR 870.2700
Device class
Class II
Review panel
Cardiovascular
Applicant
Ascent Healthcare Solutions 10232 S. 51st St., Phoenix AZ
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NLF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260