Cleared Traditional

K843846 - UNIVERSAL-BODYTEST

K843846 is an FDA 510(k) clearance for UNIVERSAL-BODYTEST, manufactured by Erich Jaeger, Inc.. The device is a Class 2 Anesthesiology device with product code CCM cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K843846 · Erich Jaeger, Inc. · Anesthesiology device
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Feb 1985
Decision
136d
Days
Class 2
Risk

K843846 is an FDA 510(k) clearance for the UNIVERSAL-BODYTEST. Classified as Plethysmograph, Pressure (product code CCM), Class II - Special Controls.

Submitted by Erich Jaeger, Inc. (Walker, US). The FDA issued a Cleared decision on February 14, 1985 after a review of 136 days - within the typical 510(k) review window.

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 Erich Jaeger, Inc. devices

FDA 510(k) Submission Details - K843846

510(k) Number K843846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1984
Decision Date February 14, 1985
Days to Decision 136 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
4d faster than avg
Panel avg: 140d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCM Device Classification - Class 2, Special Controls

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.