PIKOS 01 & PIKOS E 01 Implantable Pacemaker Pulse-Generator
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K914109 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
- SESE Substantially Equivalent FDA 510(k)
The PIKOS 01 & PIKOS E 01 are implantable pacemaker pulse-generators designed to regulate heart rhythm in patients with bradycardia or other cardiac conduction disorders. These devices deliver electrical impulses to stimulate the heart muscle, ensuring proper pacing and maintaining cardiac function when the natural pacemaker is insufficient or non-functional.
These devices are intended for surgical implantation and are classified as Class III medical devices under FDA regulations. Supplied sterile and intended for single-use, they are regulated under the FDA’s 510(k) clearance process with a traditional review pathway. The PIKOS 01 & PIKOS E 01 are authorized for use in cardiovascular applications and comply with the regulatory requirements outlined in 21 CFR 870.3610.
Frequently asked questions
What types of heart conditions are the PIKOS 01 & PIKOS E 01 designed to address, and how do they work?
The PIKOS 01 & PIKOS E 01 are implantable pacemaker pulse-generators intended to regulate heart rhythm in patients with bradycardia or other cardiac conduction disorders. These devices deliver controlled electrical impulses to stimulate the heart muscle, compensating for insufficient or non-functional natural pacemaker activity. They ensure proper pacing to maintain cardiac function when the heart’s electrical system fails to do so on its own.
Are the PIKOS 01 & PIKOS E 01 meant for single-use or can they be reused after implantation?
The PIKOS 01 & PIKOS E 01 are supplied sterile and intended for single-use only. This design ensures patient safety by preventing contamination or degradation from repeated exposure to bodily fluids or surgical environments. Reuse is not recommended or supported by the manufacturer.
What regulatory pathway was followed for FDA clearance of these devices, and what does that mean for clinicians?
The PIKOS 01 & PIKOS E 01 were cleared through the FDA’s 510(k) process with a traditional review pathway, meaning their safety and performance were evaluated by the agency to determine they are substantially equivalent to a legally marketed predicate device. This clearance confirms compliance with 21 CFR 870.3610 and ensures the devices meet FDA standards for implantable pacemaker pulse-generators, providing clinicians with confidence in their regulatory standing.
How are these devices classified under FDA regulations, and why does that matter?
The PIKOS 01 & PIKOS E 01 are classified as Class III medical devices under FDA regulations. This classification is the highest risk category for medical devices and requires pre-market approval (or, in this case, 510(k) clearance) to ensure rigorous evaluation of safety and effectiveness. It matters because it signals that these devices undergo stringent scrutiny due to their critical role in life-sustaining or life-supporting functions, such as regulating heart rhythm.
What is the primary difference between the PIKOS 01 and the PIKOS E 01 models, if any?
While the provided data does not specify technical differences between the PIKOS 01 and PIKOS E 01, the naming convention suggests a potential variation in features or capabilities (e.g., 'E' may denote an enhanced or specialized version). Clinicians should refer to the manufacturer’s detailed product documentation or technical specifications for precise distinctions, such as pacing algorithms, battery life, or additional functionalities. The regulatory data confirms both models are substantially equivalent and cleared under the same 510(k) pathway.
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. Sources consulted: Bf3 Fahrzeuge Begleitung WVZ Anlagen BF3 Vermietung PIKOS Berlin, Ch. Pikos Schwertrans-Service GmbH | Zeestow - Facebook, Ch. Pikos Schwertrans-Service GmbH | 033234 21999 | Wustermark
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K914109 | Class III | Active |
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Manufacturer
- Manufacturer
- Biotronik, GmbH & Co.
Sources (1)
- FDA 510(k) K914109 24 fields · synced Sep 18, 2026