Cleared Traditional

K800869 - MODEL PM-20(N)(R)CO2 PATIENT MONITOR/ALA

K800869 is an FDA 510(k) clearance for MODEL PM-20(N)CO2 PATIENT MONITOR/ALA, manufactured by Cavitron Corp.. The device is a Class 2 Anesthesiology device with product code CCK cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K800869 · Cavitron Corp. · Anesthesiology device
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May 1980
Decision
41d
Days
Class 2
Risk

K800869 is an FDA 510(k) clearance for the MODEL PM-20(N)(R)CO2 PATIENT MONITOR/ALA. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Cavitron Corp. (Mchenry, US). The FDA issued a Cleared decision on May 28, 1980 after a review of 41 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cavitron Corp. devices

FDA 510(k) Submission Details - K800869

510(k) Number K800869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1980
Decision Date May 28, 1980
Days to Decision 41 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
99d faster than avg
Panel avg: 140d · This submission: 41d
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 204
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K800869.
LIFESPAN CO2
K812643 · Biochem International, Inc. · Nov 1981
RESPIRATORY INTENSIVE CARE SYSTEM (RICS)
K810927 · Allied Healthcare Products, Inc. · Apr 1981
SIEMENS-ELEMA AB CO2 MONITOR 130
K802459 · Siemens Elema AB · Oct 1980
CO 2 METER
K792155 · Boehringer Laboratories · Nov 1979
IL MODEL END TIDAL CO2 ANALYZER
K791570 · Instrumentation Laboratory CO · Sep 1979
MONITOR, BECKMAN LB-3CO2
K782138 · Beckman Instruments, Inc. · Jan 1979