Cleared Traditional

K831776 - CAPNOGRAPH

K831776 is an FDA 510(k) clearance for CAPNOGRAPH, manufactured by Datascope Corp.. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K831776

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.

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 222
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K831776.
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
ENGSTROM ELIZA CO2 ANALYZER
K823049 · Lkb Instruments, Inc. · Jan 1983
LIFESPAN CO2
K812643 · Biochem International, Inc. · Nov 1981
RESPIRATORY INTENSIVE CARE SYSTEM (RICS)
K810927 · Allied Healthcare Products, Inc. · Apr 1981