Responder 3000

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K000638 ↗

FDA product code

MKJ

Device class

Class III

Regulation

21 CFR Part 870.5310

Advisory committee

Cardiovascular

FDA decision

SESE Substantially Equivalent

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• Is the Responder 3000 designed for single-use or can it be reused in multiple emergency situations?

  The Responder 3000 is a reusable device, meaning it is built for repeated use in pre-hospital and emergency medical settings like ambulances and emergency rooms. However, proper maintenance and storage as outlined by the manufacturer are required to ensure reliability and functionality between uses.

• What types of environments is the Responder 3000 intended for, and are there any restrictions?

  The Responder 3000 is designed for use in non-MRI environments only. It is intended for emergency medical settings such as ambulances and emergency rooms, where trained personnel can operate it to deliver defibrillation and advanced heart rhythm monitoring during sudden cardiac arrest situations.

• How is the Responder 3000 supplied, and what accessories might be included?

  The Responder 3000 is supplied as a reusable device, though the specific accessories (such as pads, cables, or carrying cases) are not detailed in the provided data. For full functionality, it must be paired with appropriate defibrillation pads and used in conjunction with manufacturer-recommended training for proper operation.

• What regulatory pathway was followed for the Responder 3000’s approval, and which standards does it comply with?

  The Responder 3000 received FDA clearance through a 510(k) submission, classified as Substantially Equivalent under the Traditional clearance type. It adheres to regulatory standards outlined in 21 CFR 870.5310, with a review by the Cardiovascular (CV) Advisory Committee. This pathway confirms its compliance for use as an Automated External Defibrillator (Non-Wearable).

• Does the Responder 3000 require special training to operate, and is it suitable for untrained personnel?

  Yes, the Responder 3000 requires proper training for operation, as indicated in the device description. It is not intended for use by untrained personnel and is designed for trained emergency medical responders in pre-hospital or emergency room settings where defibrillation and advanced monitoring are needed.