# K984052: Synergy Iom System

- Pathway: 510(k) (Traditional)
- Applicant: Oxford Instruments Medical Systems
- Decided: May 17, 1999 after 185 days
- Product code: IKN (Electromyograph, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 890.1375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
31 later devices descend from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K112052: Carefusion Nicolet Edx (2012), 30 descendants of its own
- K162383: Cadwell Sierra Summit, Cadwell Sierra Ascent (2017), 12 descendants of its own
- K120979: Carefusion Nicolet Edx (2012), 12 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

## Indications for use
The Synergy IOM System is a 2, 5, or 10 channel electromyograph which provides facilities for EMG, EEG, Evoked Potentials, ECG and NCV testing to be used for Intra-Operative Monitoring.

Source page: https://510kreport.com/device/K984052
Methodology: https://510kreport.com/methodology