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FDA 510(k)

Needle Free Connector

K-Number: K213004 · 2022-05-10

ApplicantMedcaptain Life Science Co., Ltd.
Decision Date2022-05-10
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Needle Free Connector is the device name listed in this FDA 510(k) record. The listed applicant is Medcaptain Life Science Co., Ltd.. It received FDA 510(k) clearance on 2022-05-10 under 510(k) number K213004. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Needle Free Connector?

Needle Free Connector is a medical device that received FDA 510(k) clearance on 2022-05-10. The listed applicant is Medcaptain Life Science Co., Ltd.. The 510(k) number is K213004.

When did Needle Free Connector receive FDA 510(k) clearance?

Needle Free Connector received FDA 510(k) clearance on 2022-05-10, under 510(k) number K213004.

Who is the listed applicant for Needle Free Connector?

The FDA 510(k) record lists Medcaptain Life Science Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Needle Free Connector?

The FDA product code for Needle Free Connector is FPA.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07519304Effectiveness of a Needle-free Connector With Anti-reflux Technology in Reducing Complications From Long Peripheral Venous Catheters in Hospitalised Adult Patients: Randomised Clinical TrialNOT_YET_RECRUITING

Other records listing Medcaptain Life Science Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: FPA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)K251814EZ™ IV Administration SetEpic Medical Pte. , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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