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Asa Blood Tubing Lines

by Organon Teknika Corp.

510(k) K854271

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 NumberK854271 Date5 Nov 1985ClearedStatusActive

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  • Withdrawn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
FJK
Device Class
Class II
Regulation
21 CFR Part 876.5820
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Asa Blood Tubing Lines are a set of tubing lines with and without anti-regurgitation valves, used for blood tubing. They are classified as a class 2 device and are used in the medical specialties of gastroenterology and urology.

The Asa Blood Tubing Lines are supplied with a product code of FJK and are regulated under regulation number 876.5820. They have been cleared by the FDA with a traditional clearance type and are substantially equivalent to existing devices. The device has a registration number and an FDA 510(k) clearance number of K854271.

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Questions

AI-generated answers, 27 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 ASA Blood Tubing Lines used for?

    The ASA Blood Tubing Lines are used for blood tubing in the medical specialties of gastroenterology and urology, providing a set of tubing lines with and without anti-regurgitation valves to support blood flow during procedures.

  • How is the ASA Blood Tubing Lines supplied and what is its product code?

    The ASA Blood Tubing Lines are supplied as a set of tubing lines with and without anti-regurgitation valves and are identified by the product code FJK, which is used for regulatory tracking and inventory management.

  • Is the ASA Blood Tubing Lines a single-use or reusable device?

    The ASA Blood Tubing Lines are intended for single-use only, as they are designed to be discarded after one procedure to prevent cross-contamination and ensure patient safety in blood tubing applications.

  • What regulatory pathway was used for the ASA Blood Tubing Lines and what is its clearance number?

    The ASA Blood Tubing Lines received FDA clearance through the traditional 510(k) pathway, with clearance number K854271, demonstrating substantial equivalence to legally marketed predicate devices.

  • What classification and regulation number apply to the ASA Blood Tubing Lines?

    The ASA Blood Tubing Lines are classified as a Class II medical device and are regulated under 21 CFR 876.5820, which covers blood tubing sets and related accessories used in vascular access procedures.