Pediatric Defib K-Pads
FDA 510(k) K935083 · Katecho, Inc.
510(k) numberK935083
Submission
- Device name
- Pediatric Defib K-Pads
- Applicant
- Katecho, Inc.
Des Moines, IA, US - Received
- October 25, 1993
- Decision date
- July 25, 1994
- Decision
- Substantially Equivalent - Subject to Tracking Reg. (ST)
- Type
- Traditional 510(k)
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
Other 510(k)s with product code LDD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K203231 | Switched Internal PaddlesLDD · Special | Philips North America, LLC | 01/11/2021SE |
| K200849 | Tempus LS - ManualLDD · Traditional | Remote Diagnostic Technologies, Ltd. A Philips… | 07/24/2020SE |
| K182503 | Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitorsLDD · Traditional | Physio-Control, Inc. | 06/03/2019SE |
| K150349 | Rapid Hair Removal PadsLDD · Traditional | Full Power Aed | 07/14/2015SE |
| K140502 | Zoll E Series AlsLDD · Traditional | ZOLL Medical Corporation | 11/06/2014SE |
| K103651 | CardiomedLDD · Traditional | Cardio Medical Products, Inc. | 10/04/2011SE |
| K103783 | Euro Defi Pads Adult; Euro Defi Pads Adult Radiotransparent: Euro Defi Pads PediatricLDD · Traditional | Fiab Spa | 06/16/2011SE |
| K103334 | Cardio MedLDD · Traditional | Cardio Medical Products, Inc. | 01/18/2011SE |
| K103159 | Cardio Med Model A102, H104, O101, P103, and Z100LDD · Traditional | Cardio Medical Products, Inc. | 01/11/2011SE |
| K102468 | Zoll Propaq MDLDD · Special | Zoll Medical Corporation, World Wide Headquarters | 09/30/2010SE |
More from Zoll Medical Corporation, World Wide Headquarters
| 510(k) | Device | Decision |
|---|---|---|
| K012404 | K-Defib/Pace Adult Electrode, Model KDP-85DRO · Traditional | 10/12/2001SE |
| K010543 | KM-30 TENS ElectrodeGXY · Traditional | 05/23/2001SE |
| K003228 | K-Defib/Pace Multifuction Pediatric Electrode, Model KDP-70AMKJ · Traditional | 12/14/2000SE |
| K002806 | K-Defib/Pace, Model KDP-60AMKJ · Traditional | 11/21/2000SE |
| K000870 | KM-10 TENS ElectrodeGXY · Traditional | 11/07/2000SE |
| K993745 | K-Defib/Pace Adult Electrode, Model KDP-80MKJ · Traditional | 02/03/2000SE |
| K991007 | K-Defib/Pace Radiolucent Adult Electrode, Model KRT-60MKJ · Traditional | 08/23/1999SE |
| K981737 | K-Defib/Pace Adult Electrode Model Number KDP-60MKJ · Traditional | 12/09/1998SE |
| K954504 | K-Defib/Pace Pediatric ElectrodeMKJ · Traditional | 11/17/1995SE |
| K934692 | K-Defib/Pace Pediatric ElectrodeMKJ · Traditional | 01/24/1995SE |
Questions and answers
When was Pediatric Defib K-Pads cleared by the FDA?
Pediatric Defib K-Pads (K935083) received a 510(k) decision of Substantially Equivalent - Subject to Tracking Reg. on July 25, 1994, 273 days after the submission was received.
What is the product code of K935083?
The FDA product code is LDD – Dc-Defibrillator, Low-Energy, (Including Paddles), a Class II (moderate risk) device regulated under 21 CFR 870.5300.