Cleared Traditional

K980915 - VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM

K980915 is an FDA 510(k) clearance for VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM, manufactured by Valleylab, Inc.. The device is a Class 2 General Hospital device with product code FYD cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K980915 · Valleylab, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
110d
Days
Class 2
Risk

K980915 is an FDA 510(k) clearance for the VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM. Classified as Apparatus, Exhaust, Surgical (product code FYD), Class II - Special Controls.

Submitted by Valleylab, Inc. (Boulder, US). The FDA issued a Cleared decision on June 29, 1998 after a review of 110 days - within the typical 510(k) review window.

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 Valleylab, Inc. devices

FDA 510(k) Submission Details - K980915

510(k) Number K980915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1998
Decision Date June 29, 1998
Days to Decision 110 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 129d · This submission: 110d
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 15
Devices cleared under the same product code (FYD) and FDA review panel - the closest regulatory comparables to K980915.
CONMED AER DEFENSE SMOKE EVACUATOR
K091139 · Conmed Corporation · May 2009
NEPTUNE WASTE MANAGEMENT STSTEM
K012991 · Stryker Instruments · Nov 2001
STERIS SMOKE EVACUATION SYSTEM
K991167 · STERIS Corporation · Jun 1999
FILTRESSE, SMOKE FILTRATION SYSTEM, 115 VAC & 230 VAC
K952981 · Utah Medical Products, Inc. · Aug 1995
THE S.A.F.E. SYSTEM
K880890 · Pfizer Laser Systems · May 1988