510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012344Substantially Equivalent

Vanguard Reprocessed Pulse Oximeter Sensors

Stryker Sustainability Solutions, Lakeland FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012344 is the FDA 510(k) clearance record for VANGUARD REPROCESSED PULSE OXIMETER SENSORS, a class II device, cleared for Vanguard Medical Concepts, 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 88 510(k) clearances for Stryker Sustainability Solutions, from to . As of , FDA records show 3 recalls naming K012344.

Clearance record

Decision date
Received
(437 days to decision)
Product code
NLF Oximeter, Reprocessed
Regulation
21 CFR 870.2700
Device class
Class II
Review panel
Cardiovascular
Applicant
Vanguard Medical Concepts, Inc. 5307 Great Oak Dr., Lakeland FL
510(k) summary
Summary
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