Cleared Traditional

K844010 - CPNOGARD CAPNOMETER 1250

K844010 is an FDA 510(k) clearance for CPNOGARD CAPNOMETER 1250, manufactured by Novametrix Medical Systems, Inc.. The device is a Class 2 Anesthesiology device with product code CCK cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K844010 · Novametrix Medical Systems, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1985
Decision
132d
Days
Class 2
Risk

K844010 is an FDA 510(k) clearance for the CPNOGARD CAPNOMETER 1250. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Novametrix Medical Systems, Inc. (Wallingford, US). The FDA issued a Cleared decision on February 21, 1985 after a review of 132 days - within the typical 510(k) review window.

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 Novametrix Medical Systems, Inc. devices

FDA 510(k) Submission Details - K844010

510(k) Number K844010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1984
Decision Date February 21, 1985
Days to Decision 132 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
8d faster than avg
Panel avg: 140d · This submission: 132d
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 154
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K844010.
TRI-MED MODEL 112 MOISTURE TRAP
K850745 · Tri-Med, Inc. · Apr 1985
TRI-MED MODEL 126 SAMPLE LINE W/EXTENDED LIFE NAFI
K850746 · Tri-Med, Inc. · Apr 1985
TRI-MED MODEL 105 SPECIAL AIRWAY ADAPTOR
K850747 · Tri-Med, Inc. · Apr 1985
TRI-MED 610 CAPNOSTAT GAS ANALYZER
K843285 · Tri-Med, Inc. · Nov 1984
MODEL IM1074 END-TIDAL CO2 MODULE
K843970 · Gould, Inc. · Oct 1984
CO2 TEST
K843844 · Erich Jaeger, Inc. · Oct 1984