# K182542: The EPAD 2 System

- Pathway: 510(k) (Traditional)
- Applicant: Safeop Surgical, Inc.
- Decided: Feb 22, 2019 after 158 days
- Product code: GWF (Stimulator, Electrical, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K842956 (1984). 59 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132616: EPAD, Safeop Surgical, Inc. (2014) Summary page 4.
- K083124: NIM 3.0, Medtronic Xomed, Inc. (2009) Summary page 4.
- K061639: Eclipse TCD Neurovascular Workstation; Elclipse Neurological Workstation with TCD and Vascular Doppler; Cardiomon, Axon Systems, Inc. (2006) Summary page 4.
- K110410: MS-120BK Electric Stimulator (Extension Unit), Nihon Kohden Corp. (2011) Summary page 4.
- K162383: Cadwell Sierra Summit, Cadwell Sierra Ascent, Cadwell Industries, Inc. (2017) Summary page 4.

## Most influential descendants
- K213849: SafeOp 2: Neural Informatix System (2022), 4 descendants of its own
- K234092: SafeOp 3: Neural Informatix Systeem (2024), 3 descendants of its own
- K182617: ATEC IOM Accessory Instruments (2019), 3 descendants of its own
- K191723: ATEC IOM Accessory Instruments (2019), 2 descendants of its own
- K252597: Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) (2026), 1 descendant of its own

## Indications for use
The EPAD 2 system is intended for use in monitoring neurological status by recording somatosensory evoked potentials (SSEP), electromyography (EMG), or assessing the neuromuscular junction (NMJ). Neuromonitoring procedures include intracranial, extracranial, intratemporal, extratemporal, neck dissections, upper and lower extremities, spinal degenerative treatments, pedicle screw fixation, intervertebral fusion cages, rhizotomy, orthopedic surgery, open or percutaneous lumbar, thoracic, and cervical surgical procedures.

Source page: https://510kreport.com/device/K182542
Methodology: https://510kreport.com/methodology