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FDA 510(k)

Tamper Evident Cap with Male Luer Lock

K-Number: K182545 · 2019-01-11

ApplicantInternational Medical Industries, Inc.
Decision Date2019-01-11
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Tamper Evident Cap with Male Luer Lock is the device name listed in this FDA 510(k) record. The listed applicant is International Medical Industries, Inc.. It received FDA 510(k) clearance on 2019-01-11 under 510(k) number K182545. 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 Tamper Evident Cap with Male Luer Lock?

Tamper Evident Cap with Male Luer Lock is a medical device that received FDA 510(k) clearance on 2019-01-11. The listed applicant is International Medical Industries, Inc.. The 510(k) number is K182545.

When did Tamper Evident Cap with Male Luer Lock receive FDA 510(k) clearance?

Tamper Evident Cap with Male Luer Lock received FDA 510(k) clearance on 2019-01-11, under 510(k) number K182545.

Who is the listed applicant for Tamper Evident Cap with Male Luer Lock?

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

What is the FDA product code for Tamper Evident Cap with Male Luer Lock?

The FDA product code for Tamper Evident Cap with Male Luer Lock is FPA.

Other records listing International Medical Industries, Inc. 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

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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