Neoshield

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K172499 ↗

FDA Product Code

ONB

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• 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

• Jms Blood Tubing Sets

  Class II

  FDA 510(k) K032975 Active Cleared 16 Aug 2004

See all devices from JMS North America Corporation →