Cleared Traditional

K910970 - MARKSMAN ARTERIAL BLOOD GAS SYRINGE

K910970 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 222-day FDA review.

K910970 · Martech Medical Products, Inc. · Chemistry device
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Oct 1991
Decision
222d
Days
Class 2
Risk

K910970 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. (Riverside, US). The FDA issued a Cleared decision on October 15, 1991 after a review of 222 days - an extended review cycle.

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 K910970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1991
Decision Date October 15, 1991
Days to Decision 222 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
134d slower than avg
Panel avg: 88d · This submission: 222d
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 K910970.
VACUTAINER BRAND LUER ADAPTER
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VACUTAINER(R) BRAND SST(R) AND CAT TUBES
K921806 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992
QBC E-Z PREP
K913399 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1991
VACUTAINER PLUS WITH HEMOGARD CLOSURE
K901449 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1990
VENOJECT II BLOOD COLLECTION TUBES
K900309 · Terumo Medical Corp. · Mar 1990
PUMPETTE(TM)
K884111 · Helena Laboratories · Dec 1988