510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K861299Substantially Equivalent for Some Indications

Hygienic Air Purifying Device

Puridyne, Inc./Imutech, Inc., Raleigh NC / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K861299 is the FDA 510(k) clearance record for HYGIENIC AIR PURIFYING DEVICE, a class II device, cleared for Puridyne, Inc./Imutech, Inc. on under FDA product code FRF (Cleaner, Air, Medical Recirculating). FDA records list one 510(k) clearance for Puridyne, Inc./Imutech, Inc. As of , FDA records show no recalls naming K861299.

Clearance record

Decision date
Received
(107 days to decision)
Product code
FRF Cleaner, Air, Medical Recirculating
Regulation
21 CFR 880.5045
Device class
Class II
Review panel
General Hospital
Applicant
Puridyne, Inc./Imutech, Inc. 282 W. Millbrook Rd., Raleigh NC
Third party review
No

Clearances, product code FRF

Trailing 12 months
1 clearance under product code FRF in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FRF, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260