K-Defib/Pace Adult Electrode, Model KDP-85
FDA 510(k) K012404 · Katecho, Inc.
510(k) numberK012404
Submission
- Device name
- K-Defib/Pace Adult Electrode, Model KDP-85
- Applicant
- Katecho, Inc.
Des Moines, IA, US - Received
- July 30, 2001
- Decision date
- October 12, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DRO – Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5550
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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|---|---|---|---|
| K012218 | Ludlow Gradient Edge Adult & Pediatric Multifunctional ElectrodesDRO · Traditional | The Ludlow Company LP | 10/12/2001SE |
| K000660 | Escort Ii+ 400 Series (Escort Prism), Model 20400, 20401, 20403, Monitor, Models 20411…DRO · Special | Medical Data Electronics | 03/28/2000SE |
| K983232 | Padtak Pediatric Defib/Cardiovert/Pace/Monitor-Radiotransparent (2X2.25),MODEL 2602…DRO · Traditional | Tz Medical, Inc. | 09/15/1999SE |
| K983196 | Padtak Pace/Defib/Cardiovert Monitoring Electrode(S)DRO · Traditional | Tz Medical, Inc. | 09/15/1999SE |
| K974034 | Portable Intensive Care UnitDRO · Traditional | Medical Research Laboratories, Inc. | 03/02/1998SE |
| K962547 | Cardioserv PDRO · Traditional | Marquette Electronics, Inc. | 03/06/1997SE |
| K963120 | Responder 2500 Defibrillator and Cardiac Care SystemDRO · Traditional | Marquette Electronics, Inc. | 02/28/1997SE |
| K961138 | Esort II + 400 Series MonitorDRO · Traditional | Medical Data Electronics | 12/10/1996SE |
| K951593 | Lifepak 11DRO · Traditional | Physio-Control Corp. | 12/29/1995SE |
| K950856 | Zoll PD2000 Pacemaker/Advisory Defibrillator, Model PD2000, Zoll D2000 Advisory…DRO · Traditional | Zoll Medical Corp | 12/29/1995SE |
More from Zoll Medical Corp
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K940801 | K-KlipDRX · Traditional | 08/03/1994SE |
Questions and answers
When was K-Defib/Pace Adult Electrode, Model KDP-85 cleared by the FDA?
K-Defib/Pace Adult Electrode, Model KDP-85 (K012404) received a 510(k) decision of Substantially Equivalent on October 12, 2001, 74 days after the submission was received.
What is the product code of K012404?
The FDA product code is DRO – Pacemaker, Cardiac, External Transcutaneous (Non-Invasive), a Class II (moderate risk) device regulated under 21 CFR 870.5550.