Cleared Traditional

K980745 - SECOND WIND AIR PURIFIER

K980745 is an FDA 510(k) clearance for SECOND WIND AIR PURIFIER, manufactured by Monagan Ent., Inc.. The device is a Class 2 General Hospital device with product code FRA cleared through the Traditional 510(k) pathway after a 400-day FDA review.

K980745 · Monagan Ent., Inc. · General Hospital
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Apr 1999
Decision
400d
Days
Class 2
Risk

K980745 is an FDA 510(k) clearance for the SECOND WIND AIR PURIFIER. Classified as Purifier, Air, Ultraviolet, Medical (product code FRA), Class II - Special Controls.

Submitted by Monagan Ent., Inc. (Albion, US). The FDA issued a Cleared decision on April 2, 1999 after a review of 400 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6500 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Monagan Ent., Inc. devices

FDA 510(k) Submission Details - K980745

510(k) Number K980745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1998
Decision Date April 02, 1999
Days to Decision 400 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
271d slower than avg
Panel avg: 129d · This submission: 400d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRA Device Classification - Class 2, Special Controls

Product Code FRA Purifier, Air, Ultraviolet, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6500
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.