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Marksman Arterial Blood Gas Syringe

by Martech Medical Products, Inc. 2 variants

510(k) K910970

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK910970 Date15 Oct 1991ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JKA
Device Class
Class II
Regulation
21 CFR Part 862.1675
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Marksman Arterial Blood Gas Syringe is a tube, vial, system, serum separator, or blood collection device used for clinical chemistry applications. It is designed to collect arterial blood gas samples for diagnostic testing.

The device received FDA 510(k) clearance under K number K910970 with product code JKA and was determined to be substantially equivalent. It is supplied non-sterile and intended for single-use in clinical settings, with storage and handling as per standard medical device practices.

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See all devices from Martech Medical Products →

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Marksman Arterial Blood Gas Syringe used for?

    It is used to collect arterial blood gas samples for diagnostic testing in clinical chemistry applications, enabling analysis of blood pH, oxygen, and carbon dioxide levels.

  • Is the Marksman Arterial Blood Gas Syringe sterile or non-sterile when supplied?

    The device is supplied non-sterile, as stated in the specifications, and is intended for single-use in clinical settings following standard handling procedures.

  • Can the Marksman Arterial Blood Gas Syringe be reused after initial use?

    No, it is intended for single-use only, as specified in the device description, to prevent contamination and ensure sample integrity for accurate diagnostic results.

  • What regulatory clearance does the Marksman Arterial Blood Gas Syringe have?

    It received FDA 510(k) clearance under K number K910970 with product code JKA and was determined to be substantially equivalent to a legally marketed device.

  • How should the Marksman Arterial Blood Gas Syringe be stored before use?

    It should be stored and handled according to standard medical device practices, as indicated in the device data, to maintain functionality and safety prior to single-use application.