Cleared Traditional

K882941 - BLOOD GAS MIXTURE

K882941 is the FDA 510(k) clearance for BLOOD GAS MIXTURE by Swisco, Inc.. It is a Class 2 Chemistry device (product code CHL) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K882941 · Swisco, Inc. · Chemistry device
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Sep 1988
Decision
64d
Days
Class 2
Risk

K882941 is an FDA 510(k) clearance for the BLOOD GAS MIXTURE. Classified as Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (product code CHL), Class II - Special Controls.

Submitted by Swisco, Inc. (Lake Charles, US). The FDA issued a Cleared decision on September 9, 1988 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1120 - the FDA in vitro diagnostics and chemistry 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 Swisco, Inc. devices

Submission Details

510(k) Number K882941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1988
Decision Date September 09, 1988
Days to Decision 64 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 88d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1120
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 Chemistry devices follow this clearance model.

Regulatory Peers - CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph

All 84
Devices cleared under the same product code (CHL) and FDA review panel - the closest regulatory comparables to K882941.
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K871397 · Nova Biomedical Corp. · Jun 1987
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STAT PROFILE 4 ANALYZER + QUALITY CONTROL MATERIAL
K864445 · Nova Biomedical Corp. · Feb 1987