Cleared Traditional

K902230 - COLORADO COLOR IMAGING RECORDER

K902230 is an FDA 510(k) clearance for COLORADO COLOR IMAGING RECORDER, manufactured by Honeywell, Inc.. The device is a Class 1 Cardiovascular device with product code DSF cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K902230 · Honeywell, Inc. · Cardiovascular device
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Jun 1990
Decision
33d
Days
Class 1
Risk

K902230 is an FDA 510(k) clearance for the COLORADO COLOR IMAGING RECORDER. Classified as Recorder, Paper Chart (product code DSF), Class I - General Controls.

Submitted by Honeywell, Inc. (Denver, US). The FDA issued a Cleared decision on June 19, 1990 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2810 - the FDA cardiovascular device oversight 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 Honeywell, Inc. devices

FDA 510(k) Submission Details - K902230

510(k) Number K902230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1990
Decision Date June 19, 1990
Days to Decision 33 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 125d · This submission: 33d
Pathway characteristics
Predicate-based equivalence.

DSF Device Classification - Class 1, General Controls

Product Code DSF Recorder, Paper Chart
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.2810
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 - DSF Recorder, Paper Chart

All 50
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