Cleared Traditional

K832005 - JP-2 RESPIRATORY MONITORING SYSTEM

K832005 is the FDA 510(k) clearance for JP-2 RESPIRATORY MONITORING SYSTEM by Morgan Associates, Inc.. It is a Class 2 Anesthesiology device (product code CCK) cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K832005 · Morgan Associates, Inc. · Anesthesiology device
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Dec 1983
Decision
189d
Days
Class 2
Risk

K832005 is an FDA 510(k) clearance for the JP-2 RESPIRATORY MONITORING SYSTEM. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Morgan Associates, Inc. (Walker, US). The FDA issued a Cleared decision on December 29, 1983 after a review of 189 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1400 - 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 Morgan Associates, Inc. devices

Submission Details

510(k) Number K832005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1983
Decision Date December 29, 1983
Days to Decision 189 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 140d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1400
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 - CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase

All 84
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K832005.
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