Model #225-ST Shock-Trode Adult Defib Pads Sterile
510(k) K922227
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK922227 | Date11 Jun 1992 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LDD
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.5300
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The Model #225-St Shock-Trode Adult Defib Pads Sterile is a Class II cardiac event recorder manufactured by Cardiotronics, Inc. These pads are designed for use with defibrillation devices to deliver electrical shocks to the heart during cardiac emergencies.
The device is supplied sterile and is intended for single-use applications. It received FDA 510(k) clearance on June 11, 1992, with the product code LDD and regulation number 870.5300. The device is classified under the cardiovascular medical specialty and is not indicated for MRI use.
Other devices from Cardiotronics, Inc.
Questions
AI-generated answers, 22 Sep 2026
What is the Model #225-St Shock-Trode Adult Defib Pads Sterile used for?
These pads are designed for use with defibrillation devices to deliver electrical shocks to the heart during cardiac emergencies. They are Class II cardiac event recorders manufactured by Cardiotronics, Inc.
How are the Model #225-St Shock-Trode Adult Defib Pads supplied?
The device is supplied sterile and is intended for single-use applications. Each package contains the sterile pads ready for immediate use in emergency cardiac situations.
What is the regulatory status of the Model #225-St Shock-Trode Adult Defib Pads?
The device received FDA 510(k) clearance on June 11, 1992, with product code LDD and regulation number 870.5300. It is classified under the cardiovascular medical specialty and is not indicated for MRI use.
Can the Model #225-St Shock-Trode Adult Defib Pads be reused?
No, these pads are intended for single-use applications only. After use, they should be properly disposed of according to medical waste protocols to ensure safety and prevent cross-contamination.