Cleared Traditional

K924731 - PLUMESAFE(TM) 1201 SMOKE EVACUATION SYSTEM (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K924731 · Buffalo Filter Co., Inc. · General Hospital
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Sep 1993
Decision
356d
Days
Class 2
Risk

K924731 is an FDA 510(k) clearance for the PLUMESAFE(TM) 1201 SMOKE EVACUATION SYSTEM. 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 September 13, 1993 after a review of 356 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

Submission Details

510(k) Number K924731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1992
Decision Date September 13, 1993
Days to Decision 356 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
227d slower than avg
Panel avg: 129d · This submission: 356d
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.

Regulatory Peers - FYD Apparatus, Exhaust, Surgical

All 74
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