FDA 510(k)

Lyka® PORT Needle Free Access Device (4170Y)

K-Number: K241058 · 2024-12-18

Decision Date2024-12-18

Product CodeFPA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

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

When was Lyka® PORT Needle Free Access Device (4170Y) approved by the FDA?

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

What company makes Lyka® PORT Needle Free Access Device (4170Y)?

Lyka® PORT Needle Free Access Device (4170Y) is manufactured by Quest Medical, Inc..

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.

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Related PubMed Literature

PMID: 41982627 Cybersecurity breaches in medical devices: analyzing FDA safety communications in response to patient security concerns. Frontiers in digital health (2026) PMID: 41672626 [Regulatory Requirements and Considerations of Aesthetic Injection Medical Devices in China, the USA and the European Union]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2026) PMID: 41613088 Orphan medical devices: addressing the regulatory and access gaps in the EU and US. Frontiers in public health (2025) PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025)

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Related Devices (Code: FPA)

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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.