Kurin Blood Culture Collection Set with Kurin Lock Technology
FDA 510(k)Class II (US FDA 510(k))
by Kurin, Inc.
Identifiers
- 510(k) Number
- K220677 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 Kurin Blood Culture Collection Set with Kurin Lock Technology is a sterile, single-use device designed for blood culture collection. It includes a vasculature connection (such as a winged needle or male luer connection), flexible tubing, Kurin Lock, and a blood culture bottle holder when supplied. The Kurin Lock is intended to receive a portion of the initial blood from a patient upon vascular access, propelled by the patient's own blood pressure, to help sideline skin contaminants.
The device is supplied sterile and intended for single-use only. It is used in clinical settings for collecting blood cultures to support microbiological testing. The device received FDA 510(k) clearance under K220677 with product code JKA and is classified under the Clinical Chemistry advisory committee. No MRI safety information or storage conditions are provided in the data.
Frequently asked questions
What is the Kurin Blood Culture Collection Set with Kurin Lock Technology used for?
It is designed for blood culture collection in clinical settings to support microbiological testing. The Kurin Lock technology captures a portion of the initial blood from vascular access, using the patient's own blood pressure to help sideline skin contaminants that could compromise culture accuracy.
Is the Kurin Blood Culture Collection Set sterile and intended for single-use or reuse?
The device is supplied sterile and intended for single-use only. It is not designed for reprocessing or reuse, as stated in the device description, to maintain sterility and prevent cross-contamination between patients.
What components are included in the Kurin Blood Culture Collection Set?
The set includes a vasculature connection (such as a winged needle or male luer connection), flexible tubing, Kurin Lock, and a blood culture bottle holder when supplied. These components work together to facilitate venous access and capture initial blood flow for contamination reduction.
Does the Kurin Blood Culture Collection Set have MRI safety information or specific storage conditions provided?
No MRI safety information or storage conditions are provided in the device data. Users should refer to the labeling or manufacturer’s instructions for handling and storage guidance, as these details are not included in the available specifications.
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: Kurin Lock Instructions for Use - Kurin, Kurin® blood culture collection set: Better specimens for better ..., PDF Kurin® Blood Culture Collection Set with Kurin Lock® Technology
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220677 | Class II | Active |
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Manufacturer
- Manufacturer
- Kurin, Inc.
Sources (1)
- FDA 510(k) K220677 24 fields · synced Oct 6, 2026