K-Stim
FDA 510(k) K913031 · Katecho, Inc.
510(k) numberK913031
Submission
- Device name
- K-Stim
- Applicant
- Katecho, Inc.
Des Moines, IA, US - Received
- July 9, 1991
- Decision date
- January 30, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code GXY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262654 | Dexus Prosthetic System (MSL2, MSR2)GXY · Special | Zhejiang Qiangnao Technology Co.,Ltd | 08/27/2026SE |
| K260578 | Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US)…GXY · Traditional | Ambu A/S | 07/14/2026SE |
| K261442 | Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayGXY · Abbreviated | Cadwell Industries, Inc. | 06/26/2026SE |
| K261522 | BioWave BioWrapsGXY · Special | Biowave Corporation | 06/03/2026SE |
| K253237 | Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)GXY · Traditional | Elde Medikal Sanayi ve Ticaret Anonim Sirketi | 05/08/2026SE |
| K254183 | MR Conditional Cup ElectrodesGXY · Traditional | Technomed Europe | 05/07/2026SE |
| K252439 | Tutamen Self Adhesive ElectrodesGXY · Traditional | Dongguan Tutamen Metalwork Co., Ltd. | 05/01/2026SE |
| K253256 | myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial…GXY · Traditional | Otto Bock Healthcare Products GmbH | 04/22/2026SE |
| K260363 | Ceribell Brain Monitor HeadbandGXY · Abbreviated | Ceribell, Inc. | 04/03/2026SE |
| K260453 | Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)GXY · Special | Bionit Labs Srl | 03/12/2026SE |
More from Bionit Labs Srl
| 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 K-Stim cleared by the FDA?
K-Stim (K913031) received a 510(k) decision of Substantially Equivalent on January 30, 1992, 205 days after the submission was received.
What is the product code of K913031?
The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.