Cleared Abbreviated

K991167 - STERIS SMOKE EVACUATION SYSTEM

K991167 is an FDA 510(k) clearance for STERIS SMOKE EVACUATION SYSTEM, manufactured by STERIS Corporation. The device is a Class 2 General Hospital device with product code FYD cleared through the Abbreviated 510(k) pathway after a 57-day FDA review.

K991167 · STERIS Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
57d
Days
Class 2
Risk

K991167 is an FDA 510(k) clearance for the STERIS SMOKE EVACUATION SYSTEM. Classified as Apparatus, Exhaust, Surgical (product code FYD), Class II - Special Controls.

Submitted by STERIS Corporation (Montgomery, US). The FDA issued a Cleared decision on June 3, 1999 after a review of 57 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.5070 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all STERIS Corporation devices

FDA 510(k) Submission Details - K991167

510(k) Number K991167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1999
Decision Date June 03, 1999
Days to Decision 57 days
Submission Type Abbreviated
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
72d faster than avg
Panel avg: 129d · This submission: 57d
Pathway characteristics
Standards-based clearance path.

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 46
Devices cleared under the same product code (FYD) and FDA review panel - the closest regulatory comparables to K991167.
BUFFALO FILTER VIROSAFE ERBIUM:YAG FILTER - #VSEYAG1-4 BUFFALO FILTER VIROSAFE ERBIUM:YAG PREFILTER - #BFEYAG04PF
K983298 · Buffalo Filter Co., Inc. · Aug 1999
BUFFALO FILTER VIROSAFE HRF- #VSHRFO1
K983333 · Buffalo Filter Co., Inc. · Aug 1999
BUFFALO FILTER VIROSAFE 18 FILTER-CATALOG #VSO1801
K983364 · Buffalo Filter Co., Inc. · Aug 1999
VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM
K980915 · Valleylab, Inc. · Jun 1998
SKYVAL
K973610 · Pyramid Air Systems · Dec 1997
SMARTVAC SMOKE EVACUATION SYSTEM
K970352 · Isomedix Operations, Inc. · Nov 1997