Cleared Traditional

K943259 - 1085 ULTIMATE E PLETHYSMOGRAPH (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K943259 · Medical Graphics Corp. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Apr 1995
Decision
278d
Days
Class 2
Risk

K943259 is an FDA 510(k) clearance for the 1085 ULTIMATE E PLETHYSMOGRAPH. Classified as Plethysmograph, Pressure (product code CCM), Class II - Special Controls.

Submitted by Medical Graphics Corp. (St. Paul, US). The FDA issued a Cleared decision on April 10, 1995 after a review of 278 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1750 - 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 Medical Graphics Corp. devices

Submission Details

510(k) Number K943259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1994
Decision Date April 10, 1995
Days to Decision 278 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
139d slower than avg
Panel avg: 139d · This submission: 278d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CCM Plethysmograph, Pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1750
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.