Cleared Traditional

K832005 - JP-2 RESPIRATORY MONITORING SYSTEM

K832005 is an FDA 510(k) clearance for JP-2 RESPIRATORY MONITORING SYSTEM, manufactured by Morgan Associates, Inc.. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K832005

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.

CCK Device Classification - Class 2, Special Controls

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 242
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K832005.
540 CAPNOGRAPH
K842978 · Spacelabs, Inc. · Aug 1984
ANESTHETIC GAS MONITOR SYS
K840966 · Marquest Medical Products, Inc. · May 1984
C02 MONITOR-OIR-7101
K841498 · Nihon Kohden America, Inc. · May 1984
TRI-MED 511 INFANT RESPIRATION MONITOR
K833397 · Tri-Med, Inc. · Nov 1983
CAPNOMETER W/NEW AIRWAY ADAPTER 47210A
K831447 · Hewlett-Packard Co. · Nov 1983
ADVANTAGE #1700
K832767 · The Perkin-Elmer Corp. · Nov 1983