IKD
6 FDA 510(k) clearances · Product code
65 daysmedian time to decision
90 days90th percentile
6clearances measured
FDA profile
- Official device name
- Cable, Electrode
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.1175
- Medical specialty
- Physical Medicine
- Adverse events (MAUDE)
- 2009: 5 · 2016: 57 · 2017: 33 · 2022: 17 · 2025: 43 · 2026: 74
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ELECTRODE/EXTENSION CABLES, MODELS ATAR (K070926) | Oscor, Inc. | 2007-06-07 |
| THE LEADAWAY (K992372) | Therapy Equipment, Inc. | 1999-10-13 |
| PHYSIOMETRIX CABLE ADAPTER MODIFICATION (K935260) | Physiometrix, Inc. | 1993-12-23 |
| LIFE-SPAN CABLE (K873361) | Chemfet Corp. | 1987-11-09 |
| CLEAR LEADS-RADIOTRANSPARENT WIRES (K834583) | Quinton, Inc. | 1984-01-30 |
| R2 ESU CABLE-ADAPTER MODELS 160,161 (K800934) | R2 Corp. | 1980-05-20 |
Track IKD automatically
Every clearance here is in the API, with alerts when new ones post.