Programalith III Models 238 & 239

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K854195 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Vascutek Vascular Prothesis VP1200K/50K

  Class II

  FDA 510(k) K830016 Active Cleared 21 Dec 1983

• Vivalith 5 - MDL-201A & TDL-201A

  Class III

  FDA 510(k) K801763 Active Cleared 27 Aug 1980

• Cardiovascular Permanent Pacemaker Electrode

  Class III

  FDA 510(k) K891905 Active Cleared 5 Jun 1989

• Pacemaker Connector Plug

  Class II

  FDA 510(k) K821548 Active Cleared 2 Jun 1982

• Personal Medication Infuser

  Class II

  FDA 510(k) K830570 Active Cleared 24 Mar 1983

• Pacemaker Unipolar Adapter

  Class II

  FDA 510(k) K821547 Active Cleared 2 Jun 1982

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• Are these pacemakers designed for reuse or intended as single-patient-use devices, and how does that affect their sterility and handling requirements?

  The Programalith III Models 238 & 239 are explicitly designed for single-patient use only and are supplied sterile for direct implantation. This means each unit is intended to be used once per patient, and sterility must be maintained according to the manufacturer’s instructions prior to use. Since they are not reusable, proper handling and storage protocols are critical to preserve functionality and sterility until implantation.

• What storage conditions must be followed to ensure these devices remain functional and sterile before use?

  The Programalith III Models 238 & 239 must be stored strictly according to the manufacturer’s instructions to maintain both sterility and functionality. While the data does not specify exact storage conditions (e.g., temperature, humidity), the requirement for sterility upon supply implies they should be kept in a sealed, protected environment until use. Avoiding contamination and physical damage is essential, as these are implantable devices.

• Can these pacemakers be used in patients who require MRI scans, or are there any restrictions related to magnetic fields?

  The Programalith III Models 238 & 239 are not MRI-safe. This means they should not be used in patients who require MRI imaging, as the magnetic fields generated during an MRI could potentially interfere with the device’s function or cause harm. Always verify compatibility with imaging procedures before implantation.

• What regulatory pathway was followed for FDA clearance, and how long did the review process take?

  The Programalith III Models 238 & 239 were cleared through the Traditional 510(k) pathway, which is the standard review process for devices deemed substantially equivalent to legally marketed predecessors. The FDA review took 84 days from submission to clearance, as noted in the decision documentation. This device is classified as Class 3 under product code DXY, reflecting its role as a life-sustaining cardiovascular implant.

• Are there any specific models or variations within the Programalith III line, and how do Models 238 and 239 differ?

  The data provided only references Models 238 and 239 of the Programalith III line, with no additional specifications on differences between them. Both are implantable pacemaker pulse-generators designed for single-patient use, but without further technical details (e.g., pacing modes, battery life, or lead compatibility), the exact distinctions between the two models cannot be determined from this information alone. Always consult the manufacturer’s documentation for model-specific details.