Cleared Traditional

K910970 - MARKSMAN ARTERIAL BLOOD GAS SYRINGE

K910970 is an FDA 510(k) clearance for MARKSMAN ARTERIAL BLOOD GAS SYRINGE, manufactured by Martech Medical Products, Inc.. The device is a Class 2 Chemistry device with 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.

FDA 510(k) Submission Details - K910970

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
133d slower than avg
Panel avg: 89d · This submission: 222d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JKA Device Classification - Class 2, Special Controls

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 237
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K910970.
VACUTAINER(R) BRAND SST(R) AND CAT TUBES
K921806 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992
SEX CRIMES/SEX ASSAULT VICT/SUSPECT EVID COLL KITS
K915814 · Sirchie Finger Print Laboratories, Inc. · Mar 1992
QBC E-Z PREP
K913399 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1991
DIFF SAFE
K914129 · Marshall Levinson · Oct 1991
NEW-VENT
K911809 · Concord/Portex · Aug 1991
SYRINGE TIP CAP
K911638 · Concord/Portex · Jun 1991
K910970 · MARKSMAN ARTERIAL BLOOD GAS SYRINGE
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