Identifiers
- 510(k) Number
- K904892 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 Vacuum Bake Cycle is a sterilisation process for implantable pacemaker pulse-generator devices, classified as a Class III medical device under FDA regulations. This method ensures the removal of moisture and contaminants from the device’s components prior to final packaging, maintaining sterility and integrity for surgical implantation.
This process is used in the manufacturing environment to prepare implantable pacemaker pulse-generators for sterilisation and packaging. It is a non-invasive, reusable procedure applied to devices listed under FDA product code DXY, adhering to regulatory requirements outlined in 870.3610. The cycle is authorised under an FDA 510(k) clearance (K904892) and is intended exclusively for use in controlled manufacturing settings, not for direct patient application.
Frequently asked questions
What is the primary purpose of the Vacuum Bake Cycle in the manufacturing process of implantable pacemaker pulse-generators?
The Vacuum Bake Cycle is designed to remove moisture and contaminants from implantable pacemaker pulse-generator components before final sterilization and packaging. This ensures the devices maintain sterility and structural integrity, which is critical for safe surgical implantation.
Is the Vacuum Bake Cycle intended for direct use on patients, or is it strictly a manufacturing process?
The Vacuum Bake Cycle is exclusively for use in controlled manufacturing settings—it is not intended for direct patient application. It prepares devices for sterilization and packaging, not for intraoperative or clinical procedures.
Which types of implantable pacemaker pulse-generators are compatible with this sterilization process?
The process applies to implantable pacemaker pulse-generators listed under FDA product code DXY, as referenced in the regulatory submission. The listed FEI numbers (e.g., 3002807576) correspond to specific Medtronic models, but the cycle itself is standardized for any device falling under this classification.
How is the Vacuum Bake Cycle regulated, and what does its FDA clearance status imply?
The Vacuum Bake Cycle holds an FDA 510(k) clearance (K904892) under the Traditional review pathway, classified as a Class III device. This clearance confirms it meets regulatory requirements for sterilization processes in manufacturing, ensuring compliance with 21 CFR 870.3610—though it does not imply patient-level approval for the devices it prepares.
Can the Vacuum Bake Cycle be reused on multiple devices, or is it a single-use procedure?
The process itself is reusable in manufacturing, as it describes a standardized sterilization method applied repeatedly to components. However, each individual device undergoing the cycle must undergo the full bake cycle to remove moisture/contaminants before final packaging, ensuring sterility for each unit.
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
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K904892 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K904892 24 fields · synced Oct 6, 2026