Cleared Traditional

K895001 - TYPE EXPIRED CO2 9270, CAPNOGRAPH

K895001 is an FDA 510(k) clearance for TYPE EXPIRED CO2 9270, manufactured by S & W Medico Teknik. The device is a Class 2 Anesthesiology device with product code CCK cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K895001 · S & W Medico Teknik · Anesthesiology device
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Feb 1990
Decision
203d
Days
Class 2
Risk

K895001 is an FDA 510(k) clearance for the TYPE EXPIRED CO2 9270, CAPNOGRAPH. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by S & W Medico Teknik (Denmark, DK). The FDA issued a Cleared decision on February 22, 1990 after a review of 203 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 S & W Medico Teknik devices

FDA 510(k) Submission Details - K895001

510(k) Number K895001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1989
Decision Date February 22, 1990
Days to Decision 203 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
63d slower than avg
Panel avg: 140d · This submission: 203d
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 192
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K895001.
BIOCHEM 9100 MULTIGAS MONITOR
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SARA SATCAP
K901132 · Ppg Industries, Inc. · May 1990
TYPE 9292 INTERFACE CAPNOGRAPH
K896737 · S & W Medico Teknik · Feb 1990
MODEL AO-800PA CO2 MODULE
K894691 · Nihon Kohden America, Inc. · Dec 1989
HEWLETT-PACKARD MODEL M1016A CO2 & M1017A FI02
K896030 · Hewlett-Packard Co. · Dec 1989
OSCAROXY(TM) GAS MONITOR AND PULSE OXIMETER
K895780 · Datex Division Instrumentarium Corp. · Nov 1989