Cleared Traditional

K943227 - BUFFALO FILTER REPLACEMENT FILTER #BSUCF03

K943227 is an FDA 510(k) clearance for BUFFALO FILTER REPLACEMENT FILTER #BSUCF03, 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 366-day FDA review.

K943227 · Buffalo Filter Co., Inc. · General Hospital
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Jul 1995
Decision
366d
Days
Class 2
Risk

K943227 is an FDA 510(k) clearance for the BUFFALO FILTER REPLACEMENT FILTER #BSUCF03. 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 July 7, 1995 after a review of 366 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 - K943227

510(k) Number K943227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1994
Decision Date July 07, 1995
Days to Decision 366 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
237d slower than avg
Panel avg: 129d · This submission: 366d
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 K943227.
SMARTVAC SMOKE EVACUATION SYSTEM
K970352 · Isomedix Operations, Inc. · Nov 1997
FILTRESSE, SMOKE FILTRATION SYSTEM, 115 VAC & 230 VAC
K952981 · Utah Medical Products, Inc. · Aug 1995
BUFFALO FILTER REPLACEMENT FILTER #BSPF030
K943226 · Buffalo Filter Co., Inc. · Jul 1995
CRYSTAL VISION AND ACCESSORIES
K932230 · I.C Medical, Inc. · Feb 1994
BUFFALO FILTER REPLACEMENT FILTER #BPTU100
K930058 · Buffalo Filter Co., Inc. · Nov 1993
BUFFALO FILTER REPLACEMENT FILTER #BST300UL
K930062 · Buffalo Filter Co., Inc. · Nov 1993