510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K200500Substantially Equivalent

Molekule Air Pro RX

Molekule, Inc., San Francisco CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K200500 is the FDA 510(k) clearance record for Molekule Air Pro RX, a class II device, cleared for Molekule, Inc. on under FDA product code FRA (Purifier, Air, Ultraviolet, Medical). FDA records list 3 510(k) clearances for Molekule, Inc., from to . As of , FDA records show no recalls naming K200500.

Clearance record

Decision date
Received
(47 days to decision)
Product code
FRA Purifier, Air, Ultraviolet, Medical
Regulation
21 CFR 880.6500
Device class
Class II
Review panel
General Hospital
Applicant
Molekule, Inc. 1301 Folsom St., San Francisco CA
510(k) summary
Summary PDF
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