510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K932803Substantially Equivalent

Clestraclean(r) Room Air Purifier

Clestra Cleanroom Technology, Inc., Syracuse NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K932803 is the FDA 510(k) clearance record for CLESTRACLEAN(R) ROOM AIR PURIFIER, a class II device, cleared for Clestra Cleanroom Technology, Inc. on under FDA product code FRA (Purifier, Air, Ultraviolet, Medical). FDA records list one 510(k) clearance for Clestra Cleanroom Technology, Inc. As of , FDA records show no recalls naming K932803.

Clearance record

Decision date
Received
(337 days to decision)
Product code
FRA Purifier, Air, Ultraviolet, Medical
Regulation
21 CFR 880.6500
Device class
Class II
Review panel
General Hospital
Applicant
Clestra Cleanroom Technology, Inc. Performance Dr., Syracuse NY
510(k) summary
Summary
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