Cleared Traditional

K032400 - LAFACI

K032400 is an FDA 510(k) clearance for LAFACI, manufactured by Vision Pro, LLC. The device is a Class 2 General Hospital device with product code FYD cleared through the Traditional 510(k) pathway after a 277-day FDA review.

K032400 · Vision Pro, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
277d
Days
Class 2
Risk

K032400 is an FDA 510(k) clearance for the LAFACI. Classified as Apparatus, Exhaust, Surgical (product code FYD), Class II - Special Controls.

Submitted by Vision Pro, LLC (Washington, US). The FDA issued a Cleared decision on May 7, 2004 after a review of 277 days - an extended review 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: 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 Vision Pro, LLC devices

FDA 510(k) Submission Details - K032400

510(k) Number K032400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2003
Decision Date May 07, 2004
Days to Decision 277 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
148d slower than avg
Panel avg: 129d · This submission: 277d
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 46
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