Cleared Traditional

K973610 - SKYVAL

K973610 is an FDA 510(k) clearance for SKYVAL, manufactured by Pyramid Air Systems. The device is a Class 2 General Hospital device with product code FYD cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K973610 · Pyramid Air Systems · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
88d
Days
Class 2
Risk

K973610 is an FDA 510(k) clearance for the SKYVAL. Classified as Apparatus, Exhaust, Surgical (product code FYD), Class II - Special Controls.

Submitted by Pyramid Air Systems (Grainvalley, US). The FDA issued a Cleared decision on December 19, 1997 after a review of 88 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 Pyramid Air Systems devices

FDA 510(k) Submission Details - K973610

510(k) Number K973610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1997
Decision Date December 19, 1997
Days to Decision 88 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
41d faster than avg
Panel avg: 129d · This submission: 88d
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 45
Devices cleared under the same product code (FYD) and FDA review panel - the closest regulatory comparables to K973610.
BUFFALO FILTER VIROSAFE 18 FILTER-CATALOG #VSO1801
K983364 · Buffalo Filter Co., Inc. · Aug 1999
STERIS SMOKE EVACUATION SYSTEM
K991167 · STERIS Corporation · Jun 1999
VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM
K980915 · Valleylab, Inc. · Jun 1998
SMARTVAC SMOKE EVACUATION SYSTEM
K970352 · Isomedix Operations, Inc. · Nov 1997
FILTRESSE, SMOKE FILTRATION SYSTEM, 115 VAC & 230 VAC
K952981 · Utah Medical Products, Inc. · Aug 1995
BUFFALO FILTER REPLACEMENT FILTER #BSPF030
K943226 · Buffalo Filter Co., Inc. · Jul 1995