Cleared Traditional

K983364 - BUFFALO FILTER VIROSAFE 18 FILTER-CATALOG #VSO1801

K983364 is an FDA 510(k) clearance for BUFFALO FILTER VIROSAFE 18 FILTER-CATAL..., manufactured by Buffalo Filter Co., Inc.. The device is a Class 2 General Hospital device with product code FYD cleared through the Traditional 510(k) pathway after a 321-day FDA review.

K983364 · Buffalo Filter Co., Inc. · General Hospital
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Aug 1999
Decision
321d
Days
Class 2
Risk

K983364 is an FDA 510(k) clearance for the BUFFALO FILTER VIROSAFE 18 FILTER-CATALOG #VSO1801. Classified as Apparatus, Exhaust, Surgical (product code FYD), Class II - Special Controls.

Submitted by Buffalo Filter Co., Inc. (Buffalo, US). The FDA issued a Cleared decision on August 11, 1999 after a review of 321 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.5070 - 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 Buffalo Filter Co., Inc. devices

FDA 510(k) Submission Details - K983364

510(k) Number K983364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1998
Decision Date August 11, 1999
Days to Decision 321 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
192d slower than avg
Panel avg: 129d · This submission: 321d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FYD Device Classification - Class 2, Special Controls

Product Code FYD Apparatus, Exhaust, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5070
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 - FYD Apparatus, Exhaust, Surgical

All 45
Devices cleared under the same product code (FYD) and FDA review panel - the closest regulatory comparables to K983364.
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