Cleared Traditional

K944855 - CHROMOPHARE

K944855 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 19-day FDA review.

K944855 · Berchtold Holding GmbH · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1994
Decision
19d
Days
Class 2
Risk

K944855 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 19, 1994 after a review of 19 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Berchtold Holding GmbH devices

FDA 510(k) Submission Details - K944855

510(k) Number K944855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1994
Decision Date October 19, 1994
Days to Decision 19 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 115d · This submission: 19d
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 26
Devices cleared under the same product code (FSY) and FDA review panel - the closest regulatory comparables to K944855.
BRIGHTSTAR
K981081 · Hill-Rom, Inc. · Apr 1998
CHROMOPHARE D 500, CHROMOPHARE D 530
K974433 · Berchtold Holding GmbH · Feb 1998
CHROMOPHARE
K965130 · Berchtold Holding GmbH · Jul 1997
AMSCO SQ240 SURGICAL LIGHT
K943288 · American Sterilizer Co. · Oct 1994
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