# K183123: microTargeting Guideline 4000 5.0 System

- Pathway: 510(k) (Special)
- Applicant: FHC, Inc.
- Decided: Dec 20, 2018 after 37 days
- Product code: GZL (Electrode, Depth)
- Device class: 2
- Regulation: 21 CFR 882.1330
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K970943 (1997). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071364: Microtargeting Guideline 4000, FHC, Inc. (2007) Summary page 4.

## Most influential descendants
- K250094: Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014) (2025), 0 descendants of its own

## Recalls of this device
- Jun 17, 2020 · Class II · Z-2540-2020: An electrical sub-circuit was not properly connected. Its purpose is to eliminate the possibility of interference with proper performance of the Guideline 5 Main Processing Unit, if an ESD event (grea

## Indications for use
The microTargeting™ Guideline 4000 5.0 System is intended to record and stimulate electrophysiological activity, as well as aid in the accurate placement of electrodes and other instruments.

Source page: https://510kreport.com/device/K183123
Methodology: https://510kreport.com/methodology