Cleared Traditional

K974433 - CHROMOPHARE D 500, CHROMOPHARE D 530

K974433 is an FDA 510(k) clearance for CHROMOPHARE D 500, 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 88-day FDA review.

K974433 · Berchtold Holding GmbH · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
88d
Days
Class 2
Risk

K974433 is an FDA 510(k) clearance for the CHROMOPHARE D 500, CHROMOPHARE D 530. 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 February 20, 1998 after a review of 88 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.

FDA 510(k) Submission Details - K974433

510(k) Number K974433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1997
Decision Date February 20, 1998
Days to Decision 88 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
27d faster than avg
Panel avg: 115d · This submission: 88d
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 69
Devices cleared under the same product code (FSY) and FDA review panel - the closest regulatory comparables to K974433.
ALM PRISMALIX (PRX) SURGICAL LIGHT
K982063 · Alm Surgical Equipment, Inc. · Sep 1998
BRIGHTSTAR
K981081 · Hill-Rom, Inc. · Apr 1998
GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT
K974084 · Getinge/Castle, Inc. · Mar 1998
HANAULUX BLUE 75 AND HANAULUX BLUE 120
K973466 · Heraeus Med GmbH · Oct 1997
CHROMOPHARE
K965130 · Berchtold Holding GmbH · Jul 1997
GENIE' SINGLE CEILING AND DOUBLE CEILING
K963682 · Burton Medical Products Corp. · Nov 1996
K974433 · CHROMOPHARE D 500, CHROMOPHARE D 530
Download PDF FDA Summary Berchtold Holding GmbH