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FDA 510(k)

SURESET INFUSION SET, MODEL 8023

K-Number: K012429 · 2001-11-06

ApplicantApplied Diabetes Research, Incorporated
Decision Date2001-11-06
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SURESET INFUSION SET, MODEL 8023 is the device name listed in this FDA 510(k) record. The listed applicant is Applied Diabetes Research, Incorporated. It received FDA 510(k) clearance on 2001-11-06 under 510(k) number K012429. 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 SURESET INFUSION SET, MODEL 8023?

SURESET INFUSION SET, MODEL 8023 is a medical device that received FDA 510(k) clearance on 2001-11-06. The listed applicant is Applied Diabetes Research, Incorporated. The 510(k) number is K012429.

When did SURESET INFUSION SET, MODEL 8023 receive FDA 510(k) clearance?

SURESET INFUSION SET, MODEL 8023 received FDA 510(k) clearance on 2001-11-06, under 510(k) number K012429.

Who is the listed applicant for SURESET INFUSION SET, MODEL 8023?

The FDA 510(k) record lists Applied Diabetes Research, Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURESET INFUSION SET, MODEL 8023?

The FDA product code for SURESET INFUSION SET, MODEL 8023 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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Other records listing Applied Diabetes Research, Incorporated 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.

K033099ADR THINSET INFUSION SET MODEL, 23-106, 23-109, 43-106, 43-109K024056SURESET 3.0 ML RESERVOIR, MODEL 24-103

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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure 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)

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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