Safe Wing Cath (SWC)

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

Full name

Jms Safe Wing Cath (Swc)

510(k) Number

K121488 ↗

FDA Product Code

FOZ

Device Class

Class II

Regulation

21 CFR Part 880.5200

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Neoshield

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  FDA 510(k) K172499 Active Cleared 1 Jun 2018

• Sysloc Mini V3

  Class II

  FDA 510(k) K110157 Active Cleared 11 Feb 2011

• Jms Sysloc Mini Avf and Apheresis Needle Sets

  Class II

  FDA 510(k) K070234 Active Cleared 22 May 2007

• Jms Blunt a. V. Fistula Needle Set with Site Preparation Tool Model 820-5300, 820-6300 and 820-7300

  Class II

  FDA 510(k) K093637 Active Cleared 9 Feb 2010

• JMS Harmony A.V. Fistula Needle Set

  Class II

  FDA 510(k) K151017 Active Cleared 13 May 2015

• Jms Extension Set with Planecta, Planecta (Stand Alone Unit), Planecta Lock & Planecta Adaptor

  Class II

  FDA 510(k) K023668 Active Cleared 1 Jul 2003

See all devices from JMS North America Corporation →

• What is the JMS Safe Wing Cath (SWC) used for?

  The JMS Safe Wing Cath (SWC) is designed for short-term (less than 30 days) intravascular access in general hospital settings. It provides a secure pathway for fluid administration, blood sampling, and blood pressure monitoring. The integrated anti-stick mechanism helps minimize the risk of needle-stick injuries during catheter insertion or removal.

• How is the JMS Safe Wing Cath (SWC) supplied and should it be reused?

  The JMS Safe Wing Cath (SWC) is supplied sterile and intended for single-use only. It is classified as a short-term catheter, meaning it is not designed for prolonged or repeated use. Discarding it after one application ensures patient safety and compliance with medical device regulations.

• Does the JMS Safe Wing Cath (SWC) require any special storage conditions?

  The JMS Safe Wing Cath (SWC) is a sterile, single-use device. It should be stored in its original packaging, protected from contamination, moisture, and extreme temperatures. Follow manufacturer guidelines to maintain sterility until immediate use, as prolonged exposure to environmental conditions may compromise its integrity.

• What regulatory approval does the JMS Safe Wing Cath (SWC) hold?

  The JMS Safe Wing Cath (SWC) has received FDA 510(k) clearance under product code FOZ, confirming it meets regulatory standards for short-term intravascular catheters. This clearance is based on a determination of substantial equivalence to a predicate device, ensuring its safety and effectiveness for the intended use.

• Is there a specific advisory committee or classification associated with this device?

  The JMS Safe Wing Cath (SWC) was reviewed by the FDA’s General Hospital (HO) Advisory Committee and falls under the classification of 880.5200 for short-term intravascular catheters. This classification helps ensure the device adheres to appropriate regulatory pathways for its intended medical use.