510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K951981Substantially Equivalent

Rxair 3000

Clean Air Research & Development, Dallas TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K951981 is the FDA 510(k) clearance record for RXAIR 3000, a class II device, cleared for Clean Air Research & Development on under FDA product code FRA (Purifier, Air, Ultraviolet, Medical). FDA records list one 510(k) clearance for Clean Air Research & Development. As of , FDA records show no recalls naming K951981.

Clearance record

Decision date
Received
(168 days to decision)
Product code
FRA Purifier, Air, Ultraviolet, Medical
Regulation
21 CFR 880.6500
Device class
Class II
Review panel
General Hospital
Applicant
Clean Air Research & Development 13711 Omega Rd., Dallas TX
510(k) summary
Statement
Third party review
No

Clearances, product code FRA

Trailing 12 months

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

FDA records show no clearances under product code FRA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FRA, 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