Cleared Traditional

K930067 - BUFFALO FILTER SURGICAL MASK

K930067 is an FDA 510(k) clearance for BUFFALO FILTER SURGICAL MASK, manufactured by Buffalo Filter Co., Inc.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 328-day FDA review.

K930067 · Buffalo Filter Co., Inc. · General Hospital
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Nov 1993
Decision
328d
Days
Class 2
Risk

K930067 is an FDA 510(k) clearance for the BUFFALO FILTER SURGICAL MASK. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Buffalo Filter Co., Inc. (E. Amherst, US). The FDA issued a Cleared decision on November 30, 1993 after a review of 328 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - 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 - K930067

510(k) Number K930067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1993
Decision Date November 30, 1993
Days to Decision 328 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
199d slower than avg
Panel avg: 129d · This submission: 328d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FXX Device Classification - Class 2, Special Controls

Product Code FXX Mask, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
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 - FXX Mask, Surgical

All 484
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K930067.
FLUIDSHIELD SURGICAL/PROCEDURE MASK/M. WITH VISOR
K932137 · Tecnol Medical Products, Inc. · Apr 1994
BARRIER LASER PLUS FACE MASK
K934194 · Johnson & Johnson Medical, Inc. · Mar 1994
BARRIER EXTRA PROTECTION PLUS FACE MASK
K920108 · Johnson & Johnson Medical, Inc. · Feb 1994
TECNOL FLUIDSHIELD INFECTION CONTROL MASK
K915817 · Tecnol Medical Products, Inc. · Jan 1993
TECNOL FLUIDSHIELD W/SPLASHGUARD VIS INFEC CONT MK
K920162 · Tecnol Medical Products, Inc. · Jan 1993
TECNOL INFECTION CONTROL MASK
K920203 · Tecnol Medical Products, Inc. · Oct 1992