Cleared Traditional

K843970 - MODEL IM1074 END-TIDAL CO2 MODULE

K843970 is the FDA 510(k) clearance for MODEL IM1074 END-TIDAL CO2 MODULE by Gould, Inc.. It is a Class 2 Anesthesiology device (product code CCK) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K843970 · Gould, Inc. · Anesthesiology device
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Oct 1984
Decision
13d
Days
Class 2
Risk

K843970 is an FDA 510(k) clearance for the MODEL IM1074 END-TIDAL CO2 MODULE. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Gould, Inc. (Walker, US). The FDA issued a Cleared decision on October 24, 1984 after a review of 13 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 Gould, Inc. devices

Submission Details

510(k) Number K843970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1984
Decision Date October 24, 1984
Days to Decision 13 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
127d faster than avg
Panel avg: 140d · This submission: 13d
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 82
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K843970.
SERIES 7050 CAPNOGRAPH
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CAPNOMED
K851658 · Draeger Medical, Inc. · May 1985
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OHMEDA MODEL 5200 CO2 MONITOR
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K841498 · Nihon Kohden America, Inc. · May 1984
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