Cleared Traditional

K842325 - CAPNOMETER

K842325 is the FDA 510(k) clearance for CAPNOMETER by Sensors, Inc.. It is a Class 2 Anesthesiology device (product code CCK) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K842325 · Sensors, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1984
Decision
13d
Days
Class 2
Risk

K842325 is an FDA 510(k) clearance for the CAPNOMETER. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Sensors, Inc. (Walker, US). The FDA issued a Cleared decision on June 26, 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 Sensors, Inc. devices

Submission Details

510(k) Number K842325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1984
Decision Date June 26, 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 K842325.
CAPNOMED
K851658 · Draeger Medical, Inc. · May 1985
SERIES 7000 END TIDAL CO2 MONITORING SYSTEM
K851001 · Marquette Electronics, Inc. · May 1985
OHMEDA MODEL 5200 CO2 MONITOR
K843599 · Ohmeda Medical · Oct 1984
C02 MONITOR-OIR-7101
K841498 · Nihon Kohden America, Inc. · May 1984
CAPNOMETER W/NEW AIRWAY ADAPTER 47210A
K831447 · Hewlett-Packard Co. · Nov 1983
CAPNOGRAPH
K831776 · Datascope Corp. · Oct 1983