Crono and Crono Model 30

• • Terminated Z-0099-2015 FDA Class II ·initiated 18 Oct 2013

  Product has the potential to have a clear debris on the tip of the needle.

510(k) Number

K041414 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Microjet Crono PCA

  Class II

  FDA 510(k) K013822 Active Cleared 8 May 2002

• Crono F

  Class II

  FDA 510(k) K042085 Active Cleared 17 Sep 2004

• Microjet Quark, Model U100 or U40

  Class II

  FDA 510(k) K013807 Active Cleared 12 Dec 2001

• Microjet Crono

  Class II

  FDA 510(k) K013234 Active Cleared 26 Apr 2002

• Crono S-Pid 50

  Class II

  FDA 510(k) K091042 Active Cleared 12 May 2009

• Crono Go.

  Class II

  FDA 510(k) K052219 Active Cleared 13 Sep 2005

See all devices from Cane S.R.L. →

• What is the primary function of the Crono Model 30?

  The Crono Model 30 is a portable microinfuser designed specifically for subcutaneous infusion. It operates by delivering programmed flow rates, where the time interval between individual delivery shots decreases as the required flow rate increases.

• What type of syringes are compatible with this pump?

  This device is intended for use exclusively with 30mL sterile disposable syringes that are specifically designed for the Crono pump system. Using non-compatible syringes may affect the performance and accuracy of the infusion.

• What is the regulatory classification of the Crono Model 30?

  The Crono Model 30 is classified as a Class II medical device under regulation number 880.5725. It has received FDA 510(k) authorization for its intended use as an infusion pump.