Cleared Traditional

K863420 - VITALOGRAPH EC-50 CARBON MONOXIDE MONITOR

K863420 is an FDA 510(k) clearance for VITALOGRAPH EC-50 CARBON MONOXIDE MONITOR, manufactured by Vitalograph , Ltd.. The device is a Class 2 Anesthesiology device with product code CCJ cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K863420 · Vitalograph , Ltd. · Anesthesiology device
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Jan 1987
Decision
133d
Days
Class 2
Risk

K863420 is an FDA 510(k) clearance for the VITALOGRAPH EC-50 CARBON MONOXIDE MONITOR. Classified as Analyzer, Gas, Carbon-monoxide, Gaseous-phase (product code CCJ), Class II - Special Controls.

Submitted by Vitalograph , Ltd. (Lenexa, US). The FDA issued a Cleared decision on January 15, 1987 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1430 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Vitalograph , Ltd. devices

FDA 510(k) Submission Details - K863420

510(k) Number K863420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1986
Decision Date January 15, 1987
Days to Decision 133 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 140d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCJ Device Classification - Class 2, Special Controls

Product Code CCJ Analyzer, Gas, Carbon-monoxide, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1430
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - CCJ Analyzer, Gas, Carbon-monoxide, Gaseous-phase

All 12
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