# K171186: Cerebrotech CMS-5000

- Pathway: 510(k) (Traditional)
- Applicant: Cerebrotech Medical Systems
- Decided: Dec 8, 2017 after 228 days
- Product code: QAF (Impedance Plethysmograph, Cranial)
- Device class: 2
- Regulation: 21 CFR 870.2770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K904109 (1991). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130338: Impedimed - Bis Extra Cellular Fluid Analysis, ImpediMed Limited (2013) Summary page 5.

## Most influential descendants
- K182967: Visor System (2018), 1 descendant of its own
- K253840: STEDI Scan Device (2026), 0 descendants of its own

## Indications for use
The CMS-5000 is a bioimpedance spectroscopy device for use on adult human patients utilizing impedance ratios that are displayed as a B-DEX ratio as an aid in the assessment of fluid volume differences between the cerebral hemispheres in patients undergoing neurologic assessment. The CMS-5000 is an adjunct to standard methodologies routinely used in the clinical evaluation of intracranial fluid distribution and is not intended to be a sole determinant.

Source page: https://510kreport.com/device/K171186
Methodology: https://510kreport.com/methodology