Heartstart 911
FDA 510(k) K954609 · Laerdal Medical Corp.
510(k) numberK954609
Submission
- Device name
- Heartstart 911
- Applicant
- Laerdal Medical Corp.
Wappingers Falls, NY, US - Received
- October 4, 1995
- Decision date
- January 4, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MKJ – Automated External Defibrillators (Non-Wearable)
- Device class
- Class III (high risk)
- Regulation
- 21 CFR 870.5310
- Specialty
- Cardiovascular
This device is a non-wearable prescription use only aed. These are devices that include automated external defibrillation. Automated external defibrillators use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation. These devices are intended to be used on suspected victims of sudden cardiac arrest. A person in cardiac arrest is…
Other 510(k)s with product code MKJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K143714 | Powerheart G5 AEDMKJ · Traditional | Cardiac Science Corporation | 05/04/2015SE |
| K150198 | CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz GelMKJ · Traditional | Bio-Detek, Inc. | 05/02/2015SE |
| K150055 | OneStep Pediatric CPR Multi-Function ElectrodeMKJ · Traditional | Bio-Detek, Inc. | 05/02/2015SE |
| K142709 | samaritan PAD 450PMKJ · Traditional | Heartsine Technologies, Inc. | 03/27/2015SE |
| K133659 | Heartstart Xl+Defibrillator/Monitor with End-Tidal Carbon Dioxide MonitoringMKJ · Traditional | Philips Medical Systems | 01/23/2015SE |
| K133239 | Zoll E SeriesMKJ · Traditional | Zoll Medical Corporation, World Wide Headquarters | 01/16/2015SE |
| K142430 | LIFEPAK 15 monitor/defibrillatorMKJ · Traditional | Physio-Control, Inc. | 12/19/2014SE |
| K141795 | Batter Pack, Replacement for Physio Control Lifepak 500MKJ · Traditional | R & D Batteries, Inc. | 12/08/2014SE |
| K142915 | ZOLL X SeriesMKJ · Traditional | ZOLL Medical Corporation | 12/03/2014SE |
| K142803 | Skintact, various other tradenamesMKJ · Traditional | Leonhard Lang GmbH | 12/02/2014SE |
More from Leonhard Lang GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K251631 | The BAG manual resuscitator and accessoriesBTM · Traditional | 11/24/2025SE |
| K232111 | NeoBeat, NeoBeat MiniMWI · Traditional | 06/25/2024SE |
| K183348 | Reusable Silicone Cover CPRmeter 2LIX · Special | 12/17/2018SE |
| K173886 | CPRmeter 2 CPR Feedback DeviceLIX · Traditional | 03/23/2018SE |
| K151702 | Reusable Full Silicone CoverLIX · Special | 08/13/2015SE |
| K001742 | Resusci Inflate-A-Shield CPR BarrierCBP · Traditional | 10/06/2000SE |
| K962361 | Trachlight Stylet and Tracheal LightwandBSR · Traditional | 09/05/1996SE |
| K954771 | Trachlight Stylet & Tracheal Lightwand (Original Application Name: Stylett & Tracheal…BSR · Traditional | 05/09/1996SE |
| K950698 | Lsu 2000 Portable Suction UnitJCX · Traditional | 05/09/1995SE |
| K933048 | Laerdal(Tm) Pocket Mask, ModificationKGB · Traditional | 12/02/1993SE |
Questions and answers
When was Heartstart 911 cleared by the FDA?
Heartstart 911 (K954609) received a 510(k) decision of Substantially Equivalent on January 4, 1996, 92 days after the submission was received.
What is the product code of K954609?
The FDA product code is MKJ – Automated External Defibrillators (Non-Wearable), a Class III (high risk) device regulated under 21 CFR 870.5310.