Cleared Traditional

K782138 - MONITOR

K782138 is an FDA 510(k) clearance for MONITOR, manufactured by Beckman Instruments, Inc.. The device is a Class 2 Anesthesiology device with product code CCK cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K782138 · Beckman Instruments, Inc. · Anesthesiology device
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Jan 1979
Decision
35d
Days
Class 2
Risk

K782138 is an FDA 510(k) clearance for the MONITOR, BECKMAN LB-3CO2. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 31, 1979 after a review of 35 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 Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K782138

510(k) Number K782138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1978
Decision Date January 31, 1979
Days to Decision 35 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
105d faster than avg
Panel avg: 140d · This submission: 35d
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 150
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K782138.
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CO 2 METER
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IL MODEL END TIDAL CO2 ANALYZER
K791570 · Instrumentation Laboratory CO · Sep 1979
CAPNOMETER MODEL 47210A
K780324 · Hewlett-Packard Co. · Mar 1978
MONITOR, PATIENT, MODEL PM-I0N
K770968 · Cavitron Corp. · Jun 1977
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K770721 · The Perkin-Elmer Corp. · Apr 1977