Cleared Traditional

CAPNOCHECK PLUS (K970209) - FDA 510(k) Clearance

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

K970209 · Bci Intl., Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
87d
Days
Class 2
Risk

K970209 is an FDA 510(k) clearance for the CAPNOCHECK PLUS. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Bci Intl., Inc. (Waukesha, US). The FDA issued a Cleared decision on April 18, 1997 after a review of 87 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 Bci Intl., Inc. devices

Submission Details

510(k) Number K970209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1997
Decision Date April 18, 1997
Days to Decision 87 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 140d · This submission: 87d
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 68
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K970209.
INFINITY ETCO2 + RESPIRATORY MECHANICS POD
K003550 · Siemens Medical Solutions USA, Inc. · Mar 2001
SIEMEMNS INFINITY ETC02 POD
K992116 · Siemens Medical Solutions USA, Inc. · Jan 2000
NIHON KOHDEN TG-901T CO2 SENSOR KIT WITH ACCESSORIES
K990063 · Nihon Kohden America, Inc. · Jun 1999
NIHON KOHDEN OLG-100A POCKETCAP POCKET CO2 MONITOR WITH ACCESSORIES
K964305 · Nihon Kohden America, Inc. · Feb 1997
SIEMENS SC 9000 ETCO2 MODULE
K954632 · Siemens Medical Solutions USA, Inc. · Feb 1996
RASCAL-II RESPIRATORY AND ANESTHETIC GAS MONITOR
K944052 · Ohmeda Medical · Jul 1995