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Eclipse Blood Collection Set

by Eclipse Medcorp, LLC 510(k)

Active United States

510(k) K213690

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK213690 Date26 Oct 2022ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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, 23 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 Eclipse Blood Collection Set is a medical device used for collecting blood samples. It is designed to facilitate venipuncture and blood collection procedures in clinical settings.

This device is supplied as a single-use product and is not intended for reuse. It is regulated under FDA 510K clearance with product code JKA and is manufactured by Eclipse Medcorp, LLC.

Other devices from Eclipse Medcorp, LLC

Questions

AI-generated answers, 23 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 Eclipse Blood Collection Set used for?

    The Eclipse Blood Collection Set is a medical device designed specifically for collecting blood samples through venipuncture procedures in clinical settings.

  • Is the Eclipse Blood Collection Set reusable or single-use?

    The Eclipse Blood Collection Set is supplied as a single-use product and is not intended for reuse to ensure patient safety and prevent cross-contamination.

  • What regulatory status does the Eclipse Blood Collection Set have?

    The Eclipse Blood Collection Set is regulated under FDA 510K clearance with product code JKA, indicating it has been determined to be substantially equivalent to predicate devices.

  • Who manufactures the Eclipse Blood Collection Set?

    The Eclipse Blood Collection Set is manufactured by Eclipse Medcorp, LLC, located in The Colony, Texas.