Cleared Traditional

CAPNOMETER W/NEW AIRWAY ADAPTER 47210A (K831447) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K831447 · Hewlett-Packard Co. · Anesthesiology device
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Nov 1983
Decision
200d
Days
Class 2
Risk

K831447 is an FDA 510(k) clearance for the CAPNOMETER W/NEW AIRWAY ADAPTER 47210A. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Hewlett-Packard Co. (Mchenry, US). The FDA issued a Cleared decision on November 21, 1983 after a review of 200 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 Hewlett-Packard Co. devices

Submission Details

510(k) Number K831447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1983
Decision Date November 21, 1983
Days to Decision 200 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
61d slower than avg
Panel avg: 139d · This submission: 200d
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 58
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K831447.
MODEL AO-800PA CO2 MODULE
K894691 · Nihon Kohden America, Inc. · Dec 1989
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K896030 · Hewlett-Packard Co. · Dec 1989
C02 MONITOR-OIR-7101
K841498 · Nihon Kohden America, Inc. · May 1984
IL MODEL END TIDAL CO2 ANALYZER
K791570 · Instrumentation Laboratory CO · Sep 1979
MONITOR, BECKMAN LB-3CO2
K782138 · Beckman Instruments, Inc. · Jan 1979
CAPNOMETER MODEL 47210A
K780324 · Hewlett-Packard Co. · Mar 1978