StatLock IV Connector and Anchor Set

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K902109 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Statlock-Ipidural

  Class II

  FDA 510(k) K943038 Active Cleared 10 Apr 1995

• IV Administration Sets with Needleless Access Devices

  Class II

  FDA 510(k) K980992 Active Cleared 28 May 1998

• Statlock Securement Devices

  Class II

  FDA 510(k) K942931 Active Cleared 28 Mar 1995

• IV Administration Sets with Needle Access Devices

  Class II

  FDA 510(k) K980994 Active Cleared 29 May 1998

• Statlock Cv

  Class I

  FDA 510(k) K943147 Active Cleared 29 Sep 1994

• What types of patients can use the StatLock IV Connector and Anchor Set, and how does it accommodate different sizes?

  The StatLock IV Connector and Anchor Set is designed for use across a wide range of patients, including adults, pediatric, and neonatal cases. Its flexible design ensures secure attachment to the skin while allowing for patient comfort and mobility. The device is compatible with standard IV tubing and catheters, making it adaptable to various patient sizes without requiring additional modifications.

• Is the StatLock IV Connector and Anchor Set reusable, or is it intended for single-use only? How should it be handled upon opening?

  The StatLock IV Connector and Anchor Set is explicitly intended for single-use only, as stated in the manufacturer’s instructions. Upon opening, it must be handled using sterile technique to maintain infection control standards, as it is not sterile until the packaging is opened and prepared for use.

• Can this device be used in an MRI environment, or are there any safety concerns related to imaging?

  The StatLock IV Connector and Anchor Set is not MRI-safe, meaning it should not be used in or near MRI machines. This is explicitly noted in the device description, as the material composition or components could pose risks during magnetic resonance imaging.

• What is the regulatory pathway for this device, and which advisory committee reviewed its submission?

  The StatLock IV Connector and Anchor Set holds FDA 510(k) clearance under the reference number K902109, classified under product code FPA. Its submission was reviewed by the Orthopaedics and Rehabilitation Devices Panel (HO), though it was filed under the broader General Hospital category. The clearance was determined under the *Traditional* 510(k) review pathway.