510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K980745Substantially Equivalent

Second Wind Air Purifier

Monagan Ent., Inc., Albion NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980745 is the FDA 510(k) clearance record for SECOND WIND AIR PURIFIER, a class II device, cleared for Monagan Ent., Inc. on under FDA product code FRA (Purifier, Air, Ultraviolet, Medical). FDA records list one 510(k) clearance for Monagan Ent., Inc. As of , FDA records show no recalls naming K980745.

Clearance record

Decision date
Received
(400 days to decision)
Product code
FRA Purifier, Air, Ultraviolet, Medical
Regulation
21 CFR 880.6500
Device class
Class II
Review panel
General Hospital
Applicant
Monagan Ent., Inc. 14247 Ridge Rd., Albion NY
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