Nanos Implantable Pacemaker Pulse-Generator

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

Full name

Nanos

510(k) Number

K894239 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Neos 02

  Class III

  FDA 510(k) K894240 Active Cleared 26 Oct 1989

• Kalos 05 Pulse Generator

  Class III

  FDA 510(k) K896184 Active Cleared 18 Jan 1990

• What types of heart conditions is the Nanos pacemaker designed to treat, and how does it work?

  The Nanos is designed to treat bradycardia and conduction disorders, such as dysfunction of the sinoatrial (SA) or atrioventricular (AV) nodes, where the heart’s natural electrical signals are insufficient. It works by delivering precise electrical impulses to regulate heart rhythm and maintain consistent cardiac output. The device operates autonomously once implanted, adjusting pacing parameters as programmed to ensure proper heart function.

• Is the Nanos pacemaker intended for reuse, or is it meant to be implanted only once?

  The Nanos is explicitly intended for single-use implantation. It is supplied sterile and designed to be placed subcutaneously near the heart via a minimally invasive procedure, ensuring patient safety and sterility standards are maintained.

• What model variants of the Nanos are available, and how do I determine the right one for a patient?

  The Nanos comes in multiple model variants, including 2017865, 3005334138, and others (see full list in the provided data). The correct model is typically selected based on clinical needs, patient anatomy, and compatibility with the intended pacing therapy. Consulting the manufacturer’s guidelines or a cardiologist is recommended to ensure proper selection.

• How should the Nanos pacemaker be stored to maintain sterility before implantation?

  The Nanos must be stored according to the manufacturer’s instructions to preserve sterile packaging integrity. This typically includes keeping the device in its original, unopened packaging, protected from moisture, extreme temperatures, and physical damage. Always follow Biotronik’s storage recommendations to ensure the device remains sterile and functional until use.

• What regulatory pathway was followed for the Nanos, and what does that mean for its use in clinical practice?

  The Nanos received FDA 510(k) clearance (K894239) under the Traditional review pathway, with a decision of *Substantially Equivalent* to a predicate device. This means it meets FDA standards for safety and effectiveness as outlined in 21 CFR 870.3610 for implantable pacemaker systems. Clinicians can rely on this clearance as evidence of regulatory compliance before use.