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Blood collection tube holders

FDA 510(k)

Class II (US FDA 510(k))

510(k) K250961

by Promisemed Hangzhou Meditech Co., Ltd.

Identifiers

510(k) Number
K250961 FDA 510(k)
FDA Product Code
JKA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1675 FDA 510(k)
Regulation Number
862.1675 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Blood collection tube holders are devices used to secure blood collection tubes during venipuncture procedures. They are designed to hold tubes in place to facilitate safe and efficient blood sample collection.

These holders are supplied non-sterile and are intended for reusable use. They are used in clinical settings for blood collection procedures and have received FDA 510(k) clearance under product code JKA and K number K250961.

Frequently asked questions

What is the intended use of the blood collection tube holders?

The blood collection tube holders are designed to secure blood collection tubes during venipuncture procedures, holding tubes in place to facilitate safe and efficient blood sample collection in clinical settings.

Are the blood collection tube holders sterile or non-sterile, and are they intended for single-use or reuse?

The blood collection tube holders are supplied non-sterile and are intended for reusable use, meaning they can be cleaned and reused multiple times following appropriate cleaning and disinfection protocols.

What regulatory clearance does the blood collection tube holder have, and under what product code and K number?

The blood collection tube holder has received FDA 510(k) clearance, is substantially equivalent to a predicate device, and is classified under product code JKA with K number K250961.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Promisemed, Insulin Pen Needles Manufacturer | Promisemed, K250961 - Blood collection tube holders - FDA 510 (k), PDF K250961 - Zearou Yang Page, Blood collection tube holders (K250961) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Promisemed Hangzhou Meditech Co., Ltd.

Sources (1)

  • FDA 510(k) K250961 24 fields · synced Oct 6, 2026