Cleared Traditional

K932812 - EC 5R PLETHYSMOGRAPH

K932812 is an FDA 510(k) clearance for EC 5R PLETHYSMOGRAPH, manufactured by D. E. Hokanson, Inc.. The device is a Class 2 Anesthesiology device with product code JEH cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K932812 · D. E. Hokanson, Inc. · Anesthesiology device
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Jan 1994
Decision
218d
Days
Class 2
Risk

K932812 is an FDA 510(k) clearance for the EC 5R PLETHYSMOGRAPH. Classified as Plethysmograph, Volume (product code JEH), Class II - Special Controls.

Submitted by D. E. Hokanson, Inc. (Bellevue, US). The FDA issued a Cleared decision on January 13, 1994 after a review of 218 days - an extended review cycle.

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. 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 D. E. Hokanson, Inc. devices

FDA 510(k) Submission Details - K932812

510(k) Number K932812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1993
Decision Date January 13, 1994
Days to Decision 218 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
78d slower than avg
Panel avg: 140d · This submission: 218d
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.