# K132616: EPAD

- Pathway: 510(k) (Traditional)
- Applicant: Safeop Surgical, Inc.
- Decided: Jan 24, 2014 after 156 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: 4 generations back to K934426 (1994). 7 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093304: Protektor 32, Natus Medical, Inc. (2010) Summary page 1.
- K123843: Neuroepg System, Strohl Medical Technologies (2013) Summary page 1.

## Most influential descendants
- K182542: The EPAD 2 System (2019), 9 descendants of its own
- 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

## Indications for use
The ERAD is intended for use in monitoring neurological status by recording somatosensory evoked potentials (SSEP) or assessing the neuromuscular junction (NMJ).

Source page: https://510kreport.com/device/K132616
Methodology: https://510kreport.com/methodology