510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K203086Substantially Equivalent

X-Plo2r

Belluscura, LLC, Plano TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K203086 is the FDA 510(k) clearance record for X-PLO2R, a class II device, cleared for Belluscura, LLC on under FDA product code CAW (Generator, Oxygen, Portable). FDA records list one 510(k) clearance for Belluscura, LLC. As of , FDA records show no recalls naming K203086.

Clearance record

Decision date
Received
(140 days to decision)
Product code
CAW Generator, Oxygen, Portable
Regulation
21 CFR 868.5440
Device class
Class II
Review panel
Anesthesiology
Applicant
Belluscura, LLC 5504 Democracy Dr., Suite 200, Plano TX
510(k) summary
Statement
Third party review
No

Clearances, product code CAW

Trailing 12 months
12 clearances under product code CAW in the twelve months to October 2026, December 2025 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code CAW, trailing twelve months
MonthClearances
November 20251
December 20255
January 20260
February 20260
March 20261
April 20261
May 20261
June 20261
July 20260
August 20261
September 20261
October 20260