Cleared Traditional

K931924 - MARKSMAN ARTERIAL BLOOD GAS SYRINGE

K931924 is the FDA 510(k) clearance for MARKSMAN ARTERIAL BLOOD GAS SYRINGE by Martech Medical Products, Inc.. It is a Class 2 Chemistry device (product code JKA) cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K931924 · Martech Medical Products, Inc. · Chemistry device
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Aug 1993
Decision
109d
Days
Class 2
Risk

K931924 is an FDA 510(k) clearance for the MARKSMAN ARTERIAL BLOOD GAS SYRINGE. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Martech Medical Products, Inc. (Temecula, US). The FDA issued a Cleared decision on August 3, 1993 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1675 - 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 Martech Medical Products, Inc. devices

Submission Details

510(k) Number K931924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1993
Decision Date August 03, 1993
Days to Decision 109 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
21d slower than avg
Panel avg: 88d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1675
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 - JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

All 103
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K931924.
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VACUTAINER BRAND LUER ADAPTER
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VACUTAINER(R) BRAND SST(R) AND CAT TUBES
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