Cleared Special

K163659 - Crystal Vision

K163659 is an FDA 510(k) clearance for Crystal Vision, manufactured by I.C Medical, Inc.. The device is a Class 2 General Hospital device with product code FYD cleared through the Special 510(k) pathway after a 307-day FDA review.

K163659 · I.C Medical, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
307d
Days
Class 2
Risk

K163659 is an FDA 510(k) clearance for the Crystal Vision. 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 October 30, 2017 after a review of 307 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.5070 - 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. Elevated predicate reliance 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 - K163659

510(k) Number K163659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2016
Decision Date October 30, 2017
Days to Decision 307 days
Submission Type Special
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
178d slower than avg
Panel avg: 129d · This submission: 307d
Pathway characteristics
Modification to existing cleared device.

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 67
Devices cleared under the same product code (FYD) and FDA review panel - the closest regulatory comparables to K163659.
Megadyne Foot Switch
K191328 · Megadyne Medical Products, Inc. · Jul 2019
SafeAir Smoke Evacuator compact
K182224 · Lina Medical Aps · Feb 2019
Smoklean
K173108 · Sejong Medical Co., Ltd. · May 2018
RapidVac Smoke Evacuator System
K142335 · Covidien · Jan 2015
VISICLEAR SMOKE EVACUATION SYSTEM
K131402 · Buffalo Filter Co., Inc. · Mar 2014
CONMED AER DEFENSE SMOKE EVACUATOR
K091139 · Conmed Corporation · May 2009
K163659 · Crystal Vision
Download PDF FDA Summary I.C Medical, Inc.