Firstsave Star Biphasic, Model 9210/9200
510(k) K011901
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK011901 | Date1 Feb 2002 | StatusActive |
Recalls
-
- Terminated Z-1033-04
- Terminated Z-1034-04
Some of the high voltage capacitors in the recalled external defibrillators have had extended charge times resulting in self-test failures following which the defibrillator cannot be used/cannot be turn on.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MKJ
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.5310
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The FirstSave Star Biphasic, Models 9210/9200, is an Automated External Defibrillator (Non-Wearable) designed to deliver biphasic defibrillation shocks for the treatment of sudden cardiac arrest. This device is engineered to analyze heart rhythms and automatically deliver appropriate energy levels to restore normal sinus rhythm in patients experiencing ventricular fibrillation or pulseless ventricular tachycardia.
The FirstSave Star Biphasic is intended for use in pre-hospital and emergency settings by trained responders, including first responders, EMS personnel, and healthcare professionals. Supplied as a reusable device, it requires proper maintenance and calibration to ensure reliable operation. The device is classified as Class III under FDA regulations and holds a Traditional 510(k) clearance, with a registration number of 1218058 among others. Storage and handling must comply with manufacturer guidelines to preserve functionality and safety.
Other devices from Survivalink Corp.
Questions
AI-generated answers, 18 Sep 2026
What types of cardiac emergencies is the FirstSave Star Biphasic designed to treat, and how does it determine when to deliver a shock?
The FirstSave Star Biphasic is specifically designed to treat sudden cardiac arrest caused by ventricular fibrillation or pulseless ventricular tachycardia. It analyzes the patient’s heart rhythm automatically and delivers biphasic defibrillation shocks at appropriate energy levels to restore a normal sinus rhythm. The device is intended for use by trained responders in pre-hospital and emergency settings.
Is the FirstSave Star Biphasic a single-use device, or can it be reused after maintenance?
The FirstSave Star Biphasic is a reusable device, not single-use. However, it requires proper maintenance, calibration, and adherence to manufacturer guidelines to ensure reliable operation and safety. Regular upkeep is essential to maintain its functionality over multiple uses.
What regulatory pathway was followed for the FDA clearance of the FirstSave Star Biphasic, and what does this mean for its use?
The FirstSave Star Biphasic received a Traditional 510(k) clearance from the FDA, which means it was determined to be substantially equivalent to a legally marketed device already on the market. This clearance confirms that the device meets FDA safety and performance standards for use as an Automated External Defibrillator (Non-Wearable) in pre-hospital and emergency settings by trained responders.
Are there specific storage requirements for the FirstSave Star Biphasic to ensure it remains functional and safe for use?
Yes, the FirstSave Star Biphasic must be stored and handled according to the manufacturer’s guidelines to preserve its functionality and safety. While the data does not specify exact storage conditions, compliance with Survivalink Corp.’s instructions is critical to ensure the device operates reliably when needed in emergency situations.