# K051864: Magstim RAPID2, Magstim Super RAPID2, Models 3004-000, 3005-00

- Pathway: 510(k) (Traditional)
- Applicant: The Magstim Company, Ltd.
- Decided: Dec 21, 2005 after 166 days
- Product code: GWF (Stimulator, Electrical, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1870
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K905059 (1991). 3 ancestors in all.
10 later devices descend from it; 5 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992911: Magstim Rapid, Magstim Corporation US (2000) Summary page 1.
- K905059: High Speed Magnetic Stimulator, Cadwell Laboratories, Inc. (1991) Summary page 1.
- K926516: Dantec Magnetic Stimulator Magpro, Dantec Medical, Inc. (1993) Summary page 1.

## Most influential descendants
- K061645: Magpro, Model R30 (2006), 7 descendants of its own
- K091940: Magpro, Models R30 with Magoption, X100, X100 with Magoption (2010), 2 descendants of its own
- K160280: MagPro R20 (2016), 1 descendant of its own
- K242345: Delphi Stimulator (2024), 0 descendants of its own
- K192823: Mega-TMS (2021), 0 descendants of its own

## Recalls of this device
- Mar 23, 2020 · Class II · Z-1965-2020: It was identified that there is a potential for the Stim Interconnecting high Voltage Cable located at the rear of the Rapid2 and Horizon power supply unit to fail.
- Mar 23, 2020 · Class II · Z-1966-2020: It was identified that there is a potential for the Stim Interconnecting high Voltage Cable located at the rear of the Rapid2 and Horizon power supply unit to fail.

## Indications for use
Peripheral Nerve Stimulation

Source page: https://510kreport.com/device/K051864
Methodology: https://510kreport.com/methodology