Hewlett Packardt Hp 85 W/ Vitatron PH1 Program Hea

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K844484 ↗

FDA Product Code

KRG

Device Class

Class III

Regulation

21 CFR Part 870.3700

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Pacemakers, Vitatron's

  Class III

  FDA 510(k) K760669 Active Cleared 12 Nov 1976

• Cardiac Pacemaker P4000 Ser. & P1000

  Class III

  FDA 510(k) K791920 Active Cleared 29 Nov 1979

• Cardiac Pacemaker C4000, C1000 Ser.

  Class III

  FDA 510(k) K791921 Active Cleared 26 Oct 1979

• External Test Pulse Generator

  Class II

  FDA 510(k) K780717 Active Cleared 30 Jun 1978

• Electrode Pacemaker, Perm & Temp

  Class III

  FDA 510(k) K840668 Active Cleared 24 Sep 1984

• Endocardial Electrode

  Class III

  FDA 510(k) K810928 Active Cleared 2 Jul 1981

See all devices from Vitatron Medical BV →

• What clinical settings is this device intended for and how is it used there?

  This device, the Hewlett Packard HP-85 with Vitatron PH1 Programmer, is designed for use in clinical settings like hospitals and cardiac electrophysiology labs. It is a reusable programmer specifically for implantable pacemakers, allowing clinicians to adjust pacing parameters such as heart rate, output, and timing. These adjustments help optimize cardiac rhythm management in patients with bradycardia or conduction disorders, ensuring proper pacemaker function during diagnostic or therapeutic procedures.

• Is this device single-use or reusable, and what does that mean for maintenance and upkeep?

  This device is explicitly labeled as reusable, meaning it is intended for repeated use in clinical environments. Since it is not sterile and no MRI safety information is provided, it must be cleaned, maintained, and calibrated according to manufacturer guidelines between uses. Reusability implies the need for a robust infection control protocol and regular servicing to ensure reliable performance and patient safety.

• How was this device’s regulatory pathway determined, and what does that mean for its use today?

  The HP-85 with Vitatron PH1 Programmer received FDA 510(k) clearance under the Substantially Equivalent (SESE) designation in 1985, classified as a Class III device. This means it was deemed comparable to a legally marketed device at the time, requiring a traditional review process by the FDA’s Cardiovascular (CV) advisory committee. While the device is no longer actively cleared for new submissions, it remains compliant for use as long as it adheres to its original specifications and maintenance protocols, assuming no modifications have been made.

• What types of pacemakers can this programmer be used with, and are there any compatibility concerns?

  This device is designed to program and configure *implantable pacemakers* broadly, though the exact models or brands compatible are not specified in the data. Since it is an older device cleared in 1985, compatibility may depend on whether the pacemaker’s programming interface aligns with the HP-85’s capabilities. Clinicians should verify compatibility with the specific pacemaker model in use, as modern pacemakers may require updated or specialized programmers. Always refer to the manufacturer’s instructions for the pacemaker and programmer to avoid mismatches.

• What storage requirements should be considered for this device, given its reusable nature?

  While no explicit storage conditions are detailed in the data, as a reusable medical device, the HP-85 with Vitatron PH1 Programmer should be stored in a clean, dry environment protected from physical damage, extreme temperatures, and direct sunlight. Since it is not sterile, it should not be stored in a sterile field or with sterile supplies. Proper handling and maintenance protocols should be followed to prevent contamination or degradation of its components, ensuring it remains functional for repeated clinical use.