# K924226: Ojemann Cortical Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Radionics, Inc.
- Decided: Apr 21, 1993 after 243 days
- Product code: GYC (Electrode, Cortical)
- Device class: 2
- Regulation: 21 CFR 882.1310
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
27 later devices descend from it; 5 cite it directly.
1 of 28 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K072964: Nicolet Cortical Stimulator (2008), 23 descendants of its own
- K110410: MS-120BK Electric Stimulator (Extension Unit) (2011), 13 descendants of its own
- K182542: The EPAD 2 System (2019), 9 descendants of its own
- K162199: Cascade IOMAX Intraoperative Monitor (2017), 7 descendants of its own
- K212166: ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (2022), 5 descendants of its own

## Recalls of this device
- Mar 18, 2013 · Class II · Z-1030-2013: If the headphone jack is in use during a surgical procedure with the OCS2 and a non-intended voltage (such as static electricity) comes in contact with the outer case of the unit, that voltage could b

Source page: https://510kreport.com/device/K924226
Methodology: https://510kreport.com/methodology