Model 113 Treonic IP3 Digital Syringe Pump

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

Full name

Model 113 Treonic IP3 Digital Syringe Pu

510(k) Number

K790945 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Sp 120 Sophisticate

  Class I

  FDA 510(k) K802251 Active Cleared 23 Oct 1980

• Neocare Baby-Controlled Incubator

  Class II

  FDA 510(k) K813238 Active Cleared 22 Jan 1982

• Treonic IP5

  Class II

  FDA 510(k) K830936 Active Cleared 12 Apr 1983

• Peep/Cpap Valve

  Class II

  FDA 510(k) K781332 Active Cleared 4 Oct 1978

• Laboratory Data Mgmt System Sdms

  Class I

  FDA 510(k) K831838 Active Cleared 24 Jan 1984

• Resuscitaire

  Class II

  FDA 510(k) K830748 Active Cleared 22 Jun 1983

See all devices from Vickers America Medical Corp. →

• What types of medical settings is the Model 113 Treonic IP3 Digital Syringe Pump intended for use in?

  The Model 113 Treonic IP3 Digital Syringe Pump is specifically designed for general hospital settings, as indicated by its FDA classification and advisory committee designation. It is not intended for use in specialized clinics or home healthcare environments.

• Is the Model 113 Treonic IP3 Digital Syringe Pump reusable or single-use, and how should the disposable components be handled?

  The Model 113 Treonic IP3 Digital Syringe Pump itself is a reusable electronic unit, while its syringe components are disposable and intended for single-use. The device requires no additional sterilization beyond the manufacturer-provided packaging for the disposable parts.

• Does the Model 113 Treonic IP3 Digital Syringe Pump have any MRI compatibility restrictions?

  No, the Model 113 Treonic IP3 Digital Syringe Pump is not constrained by MRI compatibility, meaning it can be used safely in environments where MRI scans are performed without interference.

• What regulatory pathway was followed for FDA clearance of the Model 113 Treonic IP3 Digital Syringe Pump?

  The Model 113 Treonic IP3 Digital Syringe Pump received FDA 510(k) clearance (K790945) under the Traditional 510(k) Review pathway, with a decision of Substantially Equivalent (SESE). No third-party review was conducted as part of this process.

• What types of fluids can the Model 113 Treonic IP3 Digital Syringe Pump administer, and how precise is the dosing?

  The Model 113 Treonic IP3 Digital Syringe Pump is designed for controlled administration of fluids in hospital settings, enabling precise, programmable dosing via its digital interface. While the exact fluid types are not specified, its classification as an infusion pump suggests compatibility with common intravenous, irrigation, or medication delivery applications. The key feature is its ability to deliver accurate, programmable infusion rates for clinical use.