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Nanos, Pikos 01/E01, 01-A, E01-B, LP 01/LP E01

FDA 510(k)

Class III (US FDA 510(k))

510(k) K952328

by Biotronik, Inc.

Identifiers

510(k) Number
K952328 FDA 510(k)
FDA Product Code
DXY FDA 510(k)

Classification

Device Class
Class III FDA 510(k)
Legislation / Framework
21 CFR Part 870.3610 FDA 510(k)
Regulation Number
870.3610 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
ST FDA 510(k)

The Nanos, Pikos 01/E01, 01-A, E01-B, LP 01/LP E01 are implantable pacemaker pulse generators. These devices are designed to regulate heart rhythm by delivering electrical impulses to the heart muscle when needed, ensuring proper cardiac function in patients with bradycardia or other conduction disorders.

These devices are intended for surgical implantation and are classified as Class III medical devices under FDA regulations. They are supplied sterile and intended for single-use implantation, with various models available to accommodate different patient needs. The devices are subject to tracking under the FDA’s 510(k) clearance process and comply with regulatory requirements for cardiovascular implants, including MRI safety considerations as specified in the device’s labeling.

Frequently asked questions

What types of patients are these pacemaker pulse generators designed to support, and how do they function?

These devices, the Nanos and Pikos series (including models 01/E01, 01-A, E01-B, LP 01, and LP E01), are specifically designed for patients with bradycardia or conduction disorders. They regulate heart rhythm by delivering precise electrical impulses to the heart muscle when the natural electrical signals are insufficient, ensuring consistent cardiac function. The devices are implanted surgically and are tailored to accommodate varying patient needs through multiple models.

Are these devices intended for reuse, or are they meant to be implanted once and then discarded?

These pacemaker pulse generators are supplied sterile and are intended for single-use implantation only. After implantation, they are not designed for removal or reuse, aligning with standard practices for implantable cardiac devices to maintain patient safety and sterility.

What regulatory pathway was followed for these devices, and what does that mean for clinicians or buyers?

The Nanos and Pikos series underwent a Traditional 510(k) clearance process through the FDA, with a decision of *Substantially Equivalent – Subject to Tracking*. This means the devices were evaluated against a legally marketed predicate and meet FDA requirements for cardiovascular implants, including MRI safety considerations as outlined in their labeling. The classification as Class III reflects their critical role in treating life-threatening conditions, ensuring rigorous oversight.

How should these devices be stored before implantation, and what precautions should be taken?

Since these devices are supplied sterile, they must be stored in their original packaging until implantation to preserve sterility. The packaging should remain unopened and protected from contamination, moisture, or physical damage. Follow manufacturer guidelines for shelf-life and environmental conditions (e.g., temperature) to ensure optimal performance and safety before use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biotronik, Inc.

Sources (1)

  • FDA 510(k) K952328 24 fields · synced Sep 18, 2026