Cleared Traditional

K883090 - MINICAP TM 100 CAPNOMETER

K883090 is an FDA 510(k) clearance for MINICAP TM 100 CAPNOMETER, manufactured by Minesafety Appliances Co.. The device is a Class 2 Anesthesiology device with product code CCK cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K883090 · Minesafety Appliances Co. · Anesthesiology device
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Jan 1989
Decision
192d
Days
Class 2
Risk

K883090 is an FDA 510(k) clearance for the MINICAP TM 100 CAPNOMETER. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Minesafety Appliances Co. (Pittsburgh, US). The FDA issued a Cleared decision on January 30, 1989 after a review of 192 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.

FDA 510(k) Submission Details - K883090

510(k) Number K883090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1988
Decision Date January 30, 1989
Days to Decision 192 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
52d slower than avg
Panel avg: 140d · This submission: 192d
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 306
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K883090.
2ND MODIFICATION OF FEF(TM) END-TIDAL CO2 DETECTOR
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BIOCHEM 520 BREATH INDICATOR
K890874 · Biochem International, Inc. · Jun 1989
ENGSTROM ELIZA + CO2 ANALYZER
K890112 · Gambro, Inc. · Mar 1989
THE SYSTEM, SARA DIGICAP PLUS OHMEDA MINX OXIMETER
K884158 · Ppg Industries, Inc. · Jan 1989
CHRONAMED CM101
K881206 · Chronamed Corp. · Dec 1988
MODIFIED FEF(TM) END-TIDAL CO2 DETECTOR
K884080 · Fenem, Inc. · Oct 1988
K883090 · MINICAP TM 100 CAPNOMETER
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