Cleared Traditional

K960840 - C.E. VASCULAR MACHINE

K960840 is an FDA 510(k) clearance for C.E. VASCULAR MACHINE, manufactured by C.E. Diagnosis, Inc.. The device is a Class 2 Anesthesiology device with product code JEH cleared through the Traditional 510(k) pathway after a 393-day FDA review.

K960840 · C.E. Diagnosis, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
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Mar 1997
Decision
393d
Days
Class 2
Risk

K960840 is an FDA 510(k) clearance for the C.E. VASCULAR MACHINE. Classified as Plethysmograph, Volume (product code JEH), Class II - Special Controls.

Submitted by C.E. Diagnosis, Inc. (East Ellijay, US). The FDA issued a Cleared decision on March 28, 1997 after a review of 393 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1760 - 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. Elevated predicate reliance profile. 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 C.E. Diagnosis, Inc. devices

FDA 510(k) Submission Details - K960840

510(k) Number K960840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 29, 1996
Decision Date March 28, 1997
Days to Decision 393 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
253d slower than avg
Panel avg: 140d · This submission: 393d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JEH Device Classification - Class 2, Special Controls

Product Code JEH Plethysmograph, Volume
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1760
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 - JEH Plethysmograph, Volume

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