MD2 Personal Infusion System

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

510(k) Number

K896544 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Norfolk Medical NorPort

  Class II

  FDA 510(k) K871209 Active Cleared 24 Jun 1987

• Norfolk Medical Peritoneal-Access Port

  Class III

  FDA 510(k) K854593 Active Cleared 4 Feb 1986

• Vascular Access Port Changes in Mater LJT

  Class II

  FDA 510(k) K840788 Active Cleared 24 Apr 1984

• TidalPort-AP Implantable Apheresis Vascular Access Port

  Class II

  FDA 510(k) K192291 Active Cleared 20 Aug 2020

• Vascular-Access-Port LJT

  Class II

  FDA 510(k) K830000 Active Cleared 1 Mar 1983

• Norfolk Omega Port-LP Subcutaneous Implanted

  Class II

  FDA 510(k) K942784 Active Cleared 2 May 1995

See all devices from Norfolk Medical Products, Inc. →

• Is the MD2 Personal Infusion System intended for single-use or can it be reused in a clinical setting?

  The MD2 Personal Infusion System is designed as a reusable medical instrument, not for single-use. It is intended for use in controlled clinical environments like hospitals, where it must be cleaned, disinfected, and maintained according to manufacturer guidelines before each use. This aligns with its classification as a reusable infusion pump under FDA 510(k) clearance.

• How is the MD2 Personal Infusion System supplied, and is it sterile upon arrival?

  The MD2 Personal Infusion System is not sterile at the time of shipment. It is supplied as a reusable device intended for hospital use, meaning it requires cleaning, disinfection, and maintenance before clinical use. Sterility is not a feature of this reusable system, as it is designed for repeated use in controlled environments.

• What types of fluids or solutions can the MD2 Personal Infusion System administer, and is it limited to specific clinical applications?

  The MD2 Personal Infusion System is designed for the controlled delivery of fluids, including medications, nutrients, or other solutions, to patients. While it supports a range of clinical applications requiring continuous or intermittent infusion—such as general hospital use—its intended purpose is not tied to a specific medical condition or specialty. Instead, it is a programmable, portable pump for precise volume administration in ambulatory or home-based settings.

• What regulatory pathway was followed for the FDA clearance of the MD2 Personal Infusion System, and is there any involvement from third-party organizations?

  The MD2 Personal Infusion System received FDA clearance through the traditional 510(k) pathway, with no involvement from third-party organizations (as indicated by the `third_party_flag: N`). The clearance (K896544) was granted under the regulatory framework for infusion pumps, specifically under product code FRN, and was determined to be substantially equivalent to prior devices. No additional regulatory designations (e.g., MRI safety or single-use) are noted.