Cleared Traditional

K953536 - SLANT/FIN HEPA CLEAR

K953536 is an FDA 510(k) clearance for SLANT/FIN HEPA CLEAR, manufactured by Amcor, Ltd.. The device is a Class 2 General Hospital device with product code FRF cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K953536 · Amcor, Ltd. · General Hospital
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Oct 1995
Decision
95d
Days
Class 2
Risk

K953536 is an FDA 510(k) clearance for the SLANT/FIN HEPA CLEAR. Classified as Cleaner, Air, Medical Recirculating (product code FRF), Class II - Special Controls.

Submitted by Amcor, Ltd. (Long Island City, US). The FDA issued a Cleared decision on October 30, 1995 after a review of 95 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5045 - 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. Standard predicate reliance. 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 Amcor, Ltd. devices

FDA 510(k) Submission Details - K953536

510(k) Number K953536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1995
Decision Date October 30, 1995
Days to Decision 95 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 129d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRF Device Classification - Class 2, Special Controls

Product Code FRF Cleaner, Air, Medical Recirculating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5045
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.

Regulatory Peers - FRF Cleaner, Air, Medical Recirculating

All 20
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