Cleared Traditional

K930061 - BUFFALO FILTER REPLACEMENT FILTER BST312PF

K930061 is the FDA 510(k) clearance for BUFFALO FILTER REPLACEMENT FILTER BST312PF by Buffalo Filter Co., Inc.. It is a Class 2 General Hospital device (product code FYD) cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K930061 · Buffalo Filter Co., Inc. · General Hospital
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Nov 1993
Decision
300d
Days
Class 2
Risk

K930061 is an FDA 510(k) clearance for the BUFFALO FILTER REPLACEMENT FILTER BST312PF. Classified as Apparatus, Exhaust, Surgical (product code FYD), Class II - Special Controls.

Submitted by Buffalo Filter Co., Inc. (E. Amherst, US). The FDA issued a Cleared decision on November 2, 1993 after a review of 300 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. 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 Buffalo Filter Co., Inc. devices

Submission Details

510(k) Number K930061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1993
Decision Date November 02, 1993
Days to Decision 300 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
171d slower than avg
Panel avg: 129d · This submission: 300d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.