Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors
FDA 510(k) K182503 · Physio-Control, Inc.
510(k) numberK182503
Submission
- Device name
- Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors
- Applicant
- Physio-Control, Inc.
Redmond, WA, US - Received
- September 12, 2018
- Decision date
- June 3, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LDD – Dc-Defibrillator, Low-Energy, (Including Paddles)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5300
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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More from Zoll Medical Corporation, World Wide Headquarters
| 510(k) | Device | Decision |
|---|---|---|
| K253099 | LIFEPAK 15 AC Power Adapter (41577-000333)MPD · Special | 10/14/2025SE |
| K240156 | LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV…DSA · Traditional | 04/30/2024SE |
| K142430 | LIFEPAK 15 monitor/defibrillatorMKJ · Traditional | 12/19/2014SE |
| K130454 | Lifepak 20 Defibrillator/Monitor, Lifepak 20E Defibrillator/MonitorMKJ · Traditional | 08/21/2013SE |
| K123597 | Truecpr Coaching DeviceLIX · Traditional | 04/17/2013SE |
| K122600 | Lifepak 1000 DefibrillatorMKJ · Traditional | 10/11/2012SE |
| K103567 | Lifepak 15 Monitor/DefibrillatorMKJ · Traditional | 03/22/2011SE |
| K102972 | Lifepak 12MKJ · Special | 12/22/2010SE |
| K102757 | Lifenet SystemMSX · Special | 11/05/2010SE |
| K093925 | Lifenet SystemMSX · Special | 01/12/2010SE |
Questions and answers
When was Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors cleared by the FDA?
Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors (K182503) received a 510(k) decision of Substantially Equivalent on June 3, 2019, 264 days after the submission was received.
What is the product code of K182503?
The FDA product code is LDD – Dc-Defibrillator, Low-Energy, (Including Paddles), a Class II (moderate risk) device regulated under 21 CFR 870.5300.