Cleared Traditional

K935832 - CHROMOPHARE

K935832 is an FDA 510(k) clearance for CHROMOPHARE, manufactured by Berchtold Holding GmbH. The device is a Class 1 General Hospital device with product code KZF cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K935832 · Berchtold Holding GmbH · General Hospital
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Feb 1994
Decision
58d
Days
Class 1
Risk

K935832 is an FDA 510(k) clearance for the CHROMOPHARE. Classified as Device, Medical Examination, Ac Powered (product code KZF), Class I - General Controls.

Submitted by Berchtold Holding GmbH (Tuttlingen, DE). The FDA issued a Cleared decision on February 3, 1994 after a review of 58 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6320 - 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: 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 - K935832

510(k) Number K935832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1993
Decision Date February 03, 1994
Days to Decision 58 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 129d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

KZF Device Classification - Class 1, General Controls

Product Code KZF Device, Medical Examination, Ac Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6320
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KZF Device, Medical Examination, Ac Powered

All 13
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