Cleared Traditional

K896822 - SURGISMOKE

K896822 is an FDA 510(k) clearance for SURGISMOKE, manufactured by Spectro Industries, Inc.. The device is a Class 2 General Hospital device with product code FYD cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K896822 · Spectro Industries, Inc. · General Hospital
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Jan 1990
Decision
38d
Days
Class 2
Risk

K896822 is an FDA 510(k) clearance for the SURGISMOKE. Classified as Apparatus, Exhaust, Surgical (product code FYD), Class II - Special Controls.

Submitted by Spectro Industries, Inc. (Roseville, US). The FDA issued a Cleared decision on January 11, 1990 after a review of 38 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Spectro Industries, Inc. devices

FDA 510(k) Submission Details - K896822

510(k) Number K896822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1989
Decision Date January 11, 1990
Days to Decision 38 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 129d · This submission: 38d
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 16
Devices cleared under the same product code (FYD) and FDA review panel - the closest regulatory comparables to K896822.
STERIS SMOKE EVACUATION SYSTEM
K991167 · STERIS Corporation · Jun 1999
VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM
K980915 · Valleylab, Inc. · Jun 1998
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