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FDA 510(k)

Lyka® PORT Needle Free Access Device (4170Y)

K-Number: K241058 · 2024-12-18

ApplicantQuest Medical, Inc.
Decision Date2024-12-18
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Lyka® PORT Needle Free Access Device (4170Y) is the device name listed in this FDA 510(k) record. The listed applicant is Quest Medical, Inc.. It received FDA 510(k) clearance on 2024-12-18 under 510(k) number K241058. 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 Lyka® PORT Needle Free Access Device (4170Y)?

Lyka® PORT Needle Free Access Device (4170Y) is a medical device that received FDA 510(k) clearance on 2024-12-18. The listed applicant is Quest Medical, Inc.. The 510(k) number is K241058.

When did Lyka® PORT Needle Free Access Device (4170Y) receive FDA 510(k) clearance?

Lyka® PORT Needle Free Access Device (4170Y) received FDA 510(k) clearance on 2024-12-18, under 510(k) number K241058.

Who is the listed applicant for Lyka® PORT Needle Free Access Device (4170Y)?

The FDA 510(k) record lists Quest Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lyka® PORT Needle Free Access Device (4170Y)?

The FDA product code for Lyka® PORT Needle Free Access Device (4170Y) 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.

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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

View on FDA Database →

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

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