Cleared Traditional

K953935 - MED-TECH CLINICAL BLOOD GAS

K953935 is the FDA 510(k) clearance for MED-TECH CLINICAL BLOOD GAS by Medical Technical Gases Inc... It is a Class 2 Chemistry device (product code CHL) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K953935 · Medical Technical Gases Inc.. · Chemistry device
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Nov 1995
Decision
94d
Days
Class 2
Risk

K953935 is an FDA 510(k) clearance for the MED-TECH CLINICAL BLOOD GAS. Classified as Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (product code CHL), Class II - Special Controls.

Submitted by Medical Technical Gases Inc.. (Medford, US). The FDA issued a Cleared decision on November 20, 1995 after a review of 94 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Medical Technical Gases Inc.. devices

Submission Details

510(k) Number K953935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1995
Decision Date November 20, 1995
Days to Decision 94 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 88d · This submission: 94d
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
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