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Quick Sampler Holder

FDA 510(k)

Class II (US FDA 510(k))

510(k) K120490

by Nipro Medical Corporation

Identifiers

510(k) Number
K120490 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)

The Quick Sampler Holder is a Blood Collection Device designed to facilitate safe and efficient blood sampling. It consists of a double-ended 18 gauge needle integrated with a blood tube holder, enabling secure attachment to a vacuum blood collection vessel and bloodlines with y-ports. The proximal needle tip is blunt to prevent accidental needlesticks, enhancing user safety during blood collection procedures. This device is intended for use in blood banking applications, ensuring compatibility with standard blood collection systems.

The Quick Sampler Holder is supplied as a single-use, non-sterile device, intended for use in clinical chemistry settings. It is regulated under FDA 510(k) clearance (K120490) and falls under product code JKA, classified under the Clinical Chemistry advisory committee. The device requires no special storage conditions beyond standard medical supply protocols and is intended for one-time use per manufacturer specifications. No additional regulatory approvals beyond the stated 510(k) clearance are referenced in the available data.

Frequently asked questions

What is the Quick Sampler Holder designed for?

The Quick Sampler Holder is specifically designed for blood collection in clinical chemistry settings. It integrates an 18-gauge double-ended needle with a blood tube holder to securely attach to vacuum blood collection vessels and bloodlines with y-ports. This design ensures compatibility with standard blood collection systems while minimizing the risk of accidental needlesticks due to its blunt proximal needle tip.

Is the Quick Sampler Holder sterile and single-use?

The Quick Sampler Holder is supplied as a single-use device and is non-sterile. It is intended for one-time use per the manufacturer’s specifications, aligning with standard clinical protocols for blood collection devices. Sterility is not required for this application, as outlined in the device’s regulatory submission.

How should the Quick Sampler Holder be stored?

The Quick Sampler Holder requires no special storage conditions beyond standard medical supply protocols. Store in a clean, dry environment away from direct sunlight or extreme temperatures, following general guidelines for clinical blood collection devices. Ensure the packaging remains intact until immediate use to maintain device integrity.

What regulatory clearance does the Quick Sampler Holder hold?

The Quick Sampler Holder holds FDA 510(k) clearance (K120490) under the product code JKA, classified under the Clinical Chemistry advisory committee. The clearance was granted as substantially equivalent to a predicate device, following a traditional review process. No additional regulatory approvals beyond this clearance are referenced in the available data.

Can the Quick Sampler Holder be used with any blood collection system?

The Quick Sampler Holder is designed for compatibility with standard blood collection systems, including those using vacuum blood collection vessels and bloodlines with y-ports. Its dual-ended 18-gauge needle and integrated tube holder ensure secure attachment to these systems, facilitating efficient and safe blood sampling in clinical chemistry applications.

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: QUICK SAMPLER HOLDER by NIPRO MEDICAL CORPORATION | FDA 510(k) Summary, QUICK SAMPLER HOLDER (K120490) — FDA 510 (k) | Innolitics, PDF MEDICAL CORPORATION Fax: 305.592.4621 DC2721

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nipro Medical Corporation

Sources (1)

  • FDA 510(k) K120490 24 fields · synced Oct 1, 2026