Stockert CAPS1 Cardioplegic Control Module
by Sorin Biomedica, Fiat, USA, Inc. 510(k)
Active
510(k) K925661
Overview
The Stockert CAPS1 Cardioplegic Control Module is a Cardiopulmonary Bypass Detector designed to regulate and monitor cardioplegic perfusion during cardiac surgical procedures. It delivers precise control of cardioplegic solution delivery, ensuring optimal myocardial protection by maintaining consistent flow rates and pressure parameters. This device integrates with cardiopulmonary bypass systems to enhance safety and efficacy during cardiac operations, particularly in procedures requiring cardiac arrest and reperfusion.
This module is intended for use in sterile operating room environments and is classified as a single-use device under FDA regulations (Product Code: KRL). It operates within the constraints of Class II medical devices and has been granted FDA 510(k) clearance (K925661) under the Cardiovascular advisory committee. The device is regulated under 21 CFR 870.4205 and is supplied as part of a cardiopulmonary bypass system, requiring proper storage and handling to maintain functionality before use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK925661 | Date18 May 1993 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KRL
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.4205
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Sorin Biomedica, Fiat, USA, Inc.
Questions
What is the primary purpose of the Stockert CAPS1 Cardioplegic Control Module in a cardiac surgery setting?
The Stockert CAPS1 Cardioplegic Control Module is designed to regulate and monitor the delivery of cardioplegic solution during cardiac surgical procedures. It ensures precise control of flow rates and pressure parameters to protect the heart muscle (myocardium) by maintaining optimal perfusion conditions during cardiac arrest and reperfusion phases. This integration with cardiopulmonary bypass systems enhances safety and effectiveness in procedures requiring temporary heart stopping.
Is the Stockert CAPS1 Cardioplegic Control Module intended for reuse, or is it a single-use device?
The Stockert CAPS1 Cardioplegic Control Module is classified as a single-use device under FDA regulations. This classification means it is intended for use in one surgical procedure and should not be reused, as reuse could compromise sterility and functionality. Proper disposal after use is required to maintain regulatory compliance.
How should the Stockert CAPS1 Cardioplegic Control Module be stored before use in the operating room?
The device is supplied as part of a cardiopulmonary bypass system and must be stored according to the manufacturer’s instructions to preserve its functionality. Since it is intended for sterile use in the operating room, storage conditions should prevent contamination and damage. Always follow the included storage guidelines to ensure the module remains in optimal condition until deployment in a sterile environment.
What regulatory pathway was followed for FDA clearance of the Stockert CAPS1 Cardioplegic Control Module?
The Stockert CAPS1 Cardioplegic Control Module received FDA clearance through a 510(k) premarket notification process, specifically under the Cardiovascular (CV) advisory committee. The clearance (K925661) was granted in 1993, with the device classified as substantially equivalent to a predicate device. It is regulated under 21 CFR 870.4205 and falls under the Product Code KRL for cardiopulmonary bypass detectors.