Cleared Traditional

K922836 - CHROMOPHARE

K922836 is an FDA 510(k) clearance for CHROMOPHARE, manufactured by Berchtold Holding GmbH. The device is a Class 2 General & Plastic Surgery device with product code FSY cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K922836 · Berchtold Holding GmbH · General & Plastic Surgery device
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Oct 1992
Decision
119d
Days
Class 2
Risk

K922836 is an FDA 510(k) clearance for the CHROMOPHARE. Classified as Light, Surgical, Ceiling Mounted (product code FSY), Class II - Special Controls.

Submitted by Berchtold Holding GmbH (Tuttlingen, DE). The FDA issued a Cleared decision on October 9, 1992 after a review of 119 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4580 - the FDA general and plastic surgery 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 & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Berchtold Holding GmbH devices

FDA 510(k) Submission Details - K922836

510(k) Number K922836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1992
Decision Date October 09, 1992
Days to Decision 119 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 115d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FSY Device Classification - Class 2, Special Controls

Product Code FSY Light, Surgical, Ceiling Mounted
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4580
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 & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FSY Light, Surgical, Ceiling Mounted

All 27
Devices cleared under the same product code (FSY) and FDA review panel - the closest regulatory comparables to K922836.
CHROMOPHARE
K965130 · Berchtold Holding GmbH · Jul 1997
CHROMOPHARE
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SKYTRON INFINITY SERIES SURGICAL LIGHTS
K915285 · Skytron, Div. the Kmw Group, Inc. · Feb 1992
MDT/CASTLE 2000 SURGICAL LIGHTS
K914076 · Mdt Corp., Inc. · Nov 1991
SURGICAL LIGHTING-CENTRA 450
K902864 · Sds Dental, Inc. · Sep 1990