Cleared Traditional

K932230 - CRYSTAL VISION AND ACCESSORIES

K932230 is an FDA 510(k) clearance for CRYSTAL VISION AND ACCESSORIES, manufactured by I.C Medical, Inc.. The device is a Class 2 General Hospital device with product code FYD cleared through the Traditional 510(k) pathway after a 287-day FDA review.

K932230 · I.C Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
287d
Days
Class 2
Risk

K932230 is an FDA 510(k) clearance for the CRYSTAL VISION AND ACCESSORIES. Classified as Apparatus, Exhaust, Surgical (product code FYD), Class II - Special Controls.

Submitted by I.C Medical, Inc. (Phoenix, US). The FDA issued a Cleared decision on February 18, 1994 after a review of 287 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 I.C Medical, Inc. devices

FDA 510(k) Submission Details - K932230

510(k) Number K932230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1993
Decision Date February 18, 1994
Days to Decision 287 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
158d slower than avg
Panel avg: 129d · This submission: 287d
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 43
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