Pikos 01-A and Pikos E01-A Implantable Pacemaker
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K923026 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-A and Pikos E01-A are implantable pacemaker pulse-generators designed to regulate heart rhythm in patients with bradycardia or conduction disorders. These devices deliver electrical impulses to the heart muscle to maintain a consistent and appropriate heartbeat, ensuring proper cardiac function in individuals with compromised intrinsic pacing mechanisms.
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 require professional medical implantation by a qualified healthcare provider. The Pikos 01-A and Pikos E01-A are authorized under the FDA’s 510(k) clearance process, with a decision date of August 19, 1993, and are regulated under the product code DXY. Storage and handling must comply with sterile medical device protocols.
Frequently asked questions
What is the primary purpose of the Pikos 01-A and Pikos E01-A implantable pacemaker, and who should use it?
The Pikos 01-A and Pikos E01-A are designed to regulate heart rhythm in patients with bradycardia or conduction disorders by delivering electrical impulses to the heart muscle. They are intended for individuals whose intrinsic heart pacing is compromised, ensuring a consistent and appropriate heartbeat. These devices require surgical implantation by a qualified healthcare provider and are not suitable for self-administration.
Are these devices intended for single-use or can they be reused after implantation?
The Pikos 01-A and Pikos E01-A are explicitly supplied sterile and intended for single-use only. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and patient safety. Proper sterile handling and disposal protocols must be followed after implantation.
How should these devices be stored, and what precautions should be taken during handling?
Since these devices are sterile and single-use, storage must comply with standard sterile medical device protocols to maintain integrity until use. They should be kept in their original packaging, protected from contamination, and stored in a clean, dry environment away from direct sunlight or extreme temperatures. Always follow manufacturer guidelines for handling to prevent damage or compromise of sterility.
What regulatory pathway was followed for FDA clearance of these devices, and what does that mean for clinicians?
The Pikos 01-A and Pikos E01-A were cleared through the FDA’s 510(k) process, specifically under the Traditional review pathway, with a decision date of August 19, 1993. This means the manufacturer demonstrated that their device is substantially equivalent to a legally marketed predicate device (an earlier-generation pacemaker) in terms of safety and effectiveness. Clinicians can rely on this clearance as evidence of regulatory scrutiny, though ongoing clinical judgment and patient-specific factors remain critical in device selection and use.
What product code and classification does the FDA use for these devices, and why does it matter?
These devices are classified under FDA product code DXY and fall under Class III, the highest risk category for medical devices. Class III classification requires pre-market approval (or, in this case, 510(k) clearance) due to the device’s role in sustaining life or supporting life-sustaining activities. The product code helps regulators and clinicians identify the device’s intended use and associated regulatory requirements, ensuring proper handling, reporting, and compliance.
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 | K923026 | Class III | Active |
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Manufacturer
- Manufacturer
- Biotronik, GmbH & Co.
Sources (1)
- FDA 510(k) K923026 24 fields · synced Sep 18, 2026