Microjet Crono PCA

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K013822 ↗

FDA Product Code

MEA

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Crono and Crono Model 30

  Class II

  FDA 510(k) K041414 Active Cleared 8 Jul 2004

• 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 Microjet Crono PCA used for?

  The Microjet Crono PCA is designed for intravenous or subcutaneous infusion of medications, specifically to facilitate controlled pain management through Patient-Controlled Analgesia (PCA). Its microprocessor control allows precise programming of infusion flow rates and duration, ensuring accurate and consistent drug delivery in hospital settings.

• Is the Microjet Crono PCA a single-use or reusable device?

  The Microjet Crono PCA is a reusable medical device. It is supplied in a non-sterile state and must undergo proper cleaning and maintenance between uses to maintain safety and functionality. This ensures it can be used repeatedly in clinical environments while adhering to regulatory standards.

• What regulatory approval does the Microjet Crono PCA hold?

  The Microjet Crono PCA holds FDA 510(k) clearance under the Traditional 510(k) Review Process, with a decision date of May 8, 2002. It is classified as a Class II medical device and is regulated under 21 CFR 880.5725. This clearance confirms its substantial equivalence to a predicate device and compliance with U.S. regulatory requirements.

• How should the Microjet Crono PCA be stored and maintained?

  Since the Microjet Crono PCA is reusable and non-sterile, it must be cleaned and maintained thoroughly between uses to prevent contamination and ensure reliable operation. Follow manufacturer guidelines for disinfection and storage to uphold its performance and safety in clinical settings.

• Does the Microjet Crono PCA have any specific MRI safety considerations?

  The available data does not specify any particular MRI safety requirements for the Microjet Crono PCA. Clinicians should verify compatibility with MRI environments based on the device’s materials and construction, particularly if it is used in proximity to MRI machines, to avoid potential interference or safety risks.