Cleared Special

K003194 - STACKHOUSE LENS HOOD, MODEL SA-700/FS

K003194 is an FDA 510(k) clearance for STACKHOUSE LENS HOOD, manufactured by Stackhouse, Inc.. The device is a Class 2 General Hospital device with product code FYA cleared through the Special 510(k) pathway after a 14-day FDA review.

K003194 · Stackhouse, Inc. · General Hospital
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Oct 2000
Decision
14d
Days
Class 2
Risk

K003194 is an FDA 510(k) clearance for the STACKHOUSE LENS HOOD, MODEL SA-700/FS. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Stackhouse, Inc. (Palm Spring, US). The FDA issued a Cleared decision on October 26, 2000 after a review of 14 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K003194

510(k) Number K003194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2000
Decision Date October 26, 2000
Days to Decision 14 days
Submission Type Special
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
115d faster than avg
Panel avg: 129d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

FYA Device Classification - Class 2, Special Controls

Product Code FYA Gown, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
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 - FYA Gown, Surgical

All 296
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K003194.
BREATHABLE IMPERVIOUS GOWNS
K012984 · Allegiance Healthcare Corp. · Sep 2001
COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE)
K010799 · Standard Textile Co., Inc. · Jun 2001
MEDLINE BLOCKADE OR RESISTAT SURGICAL GOWNS AND SURGGICAL DRAPES
K003755 · Medline Industries, Inc. · Feb 2001
STACKHOUSE LENS HOOD, MODEL SA-700/F
K000605 · Stackhouse, Inc. · Aug 2000
KLINIDRAPE REINFORCED SURGICAL GOWNS
K000902 · Molnlycke Health Care, Inc. · Jul 2000
KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONS AND STANDARD PROTECTION
K000901 · Molnlycke Health Care, Inc. · Jul 2000
K003194 · STACKHOUSE LENS HOOD, MODEL SA-700/FS
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