510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K100815Substantially Equivalent

Oxiblue Fingertip Pulse Oximeter Model Md300c318, Oxipro Fingertip Pulse Oximeter Model Md300c316

Oxypulse, Mesa AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K100815 is the FDA 510(k) clearance record for OXIBLUE FINGERTIP PULSE OXIMETER MODEL MD300C318, OXIPRO FINGERTIP PULSE OXIMETER MODEL MD300C316, a class II device, cleared for Oxypulse on under FDA product code DQA (Oximeter). FDA records list one 510(k) clearance for Oxypulse. As of , FDA records show no recalls naming K100815.

Clearance record

Decision date
Received
(85 days to decision)
Product code
DQA Oximeter
Regulation
21 CFR 870.2700
Device class
Class II
Review panel
Cardiovascular
Applicant
Oxypulse One Macdonal Center, Mesa AZ
510(k) summary
Statement
Third party review
No

Clearances, product code DQA

Trailing 12 months
13 clearances under product code DQA in the twelve months to October 2026, December 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DQA, trailing twelve months
MonthClearances
November 20252
December 20253
January 20261
February 20262
March 20260
April 20261
May 20263
June 20260
July 20260
August 20260
September 20260
October 20261