K-Free
by Katecho LLC 510(k)
Active
510(k) K912587
Overview
The K-Free is a Low-Energy Defibrillator (Including Paddles) as classified under FDA product code LDD. This device is designed to deliver controlled electrical impulses for defibrillation, restoring normal heart rhythm during cardiac emergencies. It operates within the cardiovascular specialty and is intended for use in emergency resuscitation settings where rapid intervention is critical.
The K-Free is supplied as a reusable medical device and is regulated under FDA 510(k) clearance (K912587) as a Class 2 Cardiovascular device. It is intended for use in clinical environments where defibrillation may be required, adhering to regulatory standards outlined in 21 CFR 870.5300. No specific sterility or MRI safety information is provided in the available data, and its use is governed by the original FDA clearance from 1991.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK912587 | Date30 Jul 1991 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- LDD
- FDA applicant
- Katecho, Inc.
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.5300
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Katecho LLC
Questions
What is the K-Free defibrillator used for?
The K-Free is a low-energy defibrillator intended for use in emergency resuscitation settings. It delivers controlled electrical impulses to restore normal heart rhythm during cardiac emergencies, such as ventricular fibrillation or pulseless ventricular tachycardia. Its design prioritizes rapid intervention in situations where immediate defibrillation is critical to patient survival.
Is the K-Free a single-use or reusable device?
The K-Free is a reusable medical device. This classification allows for repeated use in clinical environments, provided it undergoes proper maintenance and cleaning between deployments. Reusability helps ensure consistent performance and cost-effectiveness in healthcare settings where defibrillation may be required frequently.
What regulatory approval does the K-Free hold?
The K-Free holds FDA 510(k) clearance (K912587) as a Class 2 Cardiovascular device, classified under FDA product code LDD (Low-Energy Defibrillator). This clearance was granted in 1991 and is governed by regulatory standards outlined in 21 CFR 870.5300. The device is considered substantially equivalent to prior-generation defibrillators, ensuring compliance with existing safety and performance requirements.
Does the K-Free come with paddles, and what is its intended clinical use?
Yes, the K-Free includes paddles as part of its design. It is specifically intended for clinical environments where defibrillation may be required, such as hospitals, emergency rooms, or pre-hospital emergency care settings. The device is tailored for use by trained healthcare professionals during cardiac arrest or other life-threatening arrhythmias where rapid defibrillation is essential to restore a stable heart rhythm.
Are there any specific storage requirements for the K-Free?
While the provided data does not specify detailed storage instructions, reusable medical devices like the K-Free generally require protection from physical damage, contamination, and environmental extremes (e.g., excessive heat, moisture, or direct sunlight). Storage should follow manufacturer guidelines to maintain functionality, sterility (if applicable to accessories), and operational readiness for emergency use. Always refer to the device’s user manual for precise storage recommendations.