Cleared Traditional

K831776 - CAPNOGRAPH

K831776 is the FDA 510(k) clearance for CAPNOGRAPH by Datascope Corp.. It is a Class 2 Anesthesiology device (product code CCK) cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K831776 · Datascope Corp. · Anesthesiology device
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Oct 1983
Decision
151d
Days
Class 2
Risk

K831776 is an FDA 510(k) clearance for the CAPNOGRAPH. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Datascope Corp. (Mchenry, US). The FDA issued a Cleared decision on October 31, 1983 after a review of 151 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 Datascope Corp. devices

Submission Details

510(k) Number K831776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1983
Decision Date October 31, 1983
Days to Decision 151 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
11d slower than avg
Panel avg: 140d · This submission: 151d
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 119
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K831776.
C02 MONITOR-OIR-7101
K841498 · Nihon Kohden America, Inc. · May 1984
CAPNOMETER W/NEW AIRWAY ADAPTER 47210A
K831447 · Hewlett-Packard Co. · Nov 1983
ADVANTAGE #1700
K832767 · The Perkin-Elmer Corp. · Nov 1983
ENGSTROM ELIZA CO2 ANALYZER
K823049 · Lkb Instruments, Inc. · Jan 1983
SIEMENS-ELEMA AB CO2 MONITOR 130
K802459 · Siemens Elema AB · Oct 1980
IL MODEL END TIDAL CO2 ANALYZER
K791570 · Instrumentation Laboratory CO · Sep 1979