Tablet Commander

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

510(k) Number

K122285 ↗

FDA Product Code

DRG

Device Class

Class II

Regulation

21 CFR Part 870.2910

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Cardiocom Commander III

  Class II

  FDA 510(k) K053303 Active Cleared 30 Dec 2005

• Commander III Non-Invasive Blood Pressure System

  Class II

  FDA 510(k) K053304 Active Cleared 30 Dec 2005

• Commander II

  Class II

  FDA 510(k) K043096 Active Cleared 24 Nov 2004

• Commander 111, Model CD300-CD399

  Class II

  FDA 510(k) K091821 Active Cleared 25 Aug 2009

• What is the Tablet Commander used for?

  The Tablet Commander is a software application designed to interface with FDA-cleared medical devices, collecting physiological data via wired or wireless protocols. It transmits patient metrics in real-time to a remote database for clinical review, supporting remote patient monitoring in both clinical and home settings. This allows healthcare providers to monitor patients remotely without needing direct physical access.

• How is the Tablet Commander supplied and does it require sterilization?

  The Tablet Commander is supplied as a reusable software solution installed on commercially available Android tablets. Since it is software-based and does not involve physical hardware that comes into direct contact with patients, no sterilization is required. This makes it cost-effective and convenient for long-term use in various environments.

• Is the Tablet Commander intended for single-use or reusable applications?

  The Tablet Commander is explicitly designed as a reusable software solution. It operates on Android tablets and is not limited by a single-use lifecycle, allowing healthcare providers to deploy it repeatedly across multiple patients and settings without replacement. This aligns with its classification as a reusable medical device software.

• What types of devices does the Tablet Commander interface with?

  The Tablet Commander interfaces with external, FDA-cleared medical devices that transmit physiological data via wired or wireless protocols. While the specific devices are not listed in the data, its regulatory classification under OpenFDA as a 'Transmitter and Receiver, Physiological Signal, Radiofrequency' suggests compatibility with a broad range of cardiovascular and monitoring devices approved for remote data transmission.

• What regulatory approval does the Tablet Commander hold?

  The Tablet Commander holds FDA 510(k) clearance under the product code DRG, with the clearance number K122285. It is classified as a Class II device under regulation 870.2910, indicating it has been determined to be substantially equivalent to a legally marketed predicate device. This approval supports its use for remote patient monitoring in clinical settings.