# K190975: Plexus SCD110 Sequential Compression Device Sleeve

- Pathway: 510(k) (Traditional)
- Applicant: Midway Medical, LLC
- Decided: Jul 22, 2019 after 98 days
- Product code: JOW (Sleeve, Limb, Compressible)
- Device class: 2
- Regulation: 21 CFR 870.5800
- 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 K991038 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141578: Devon Cirona 6200 DVT, Devon Medical (2014) Summary page 4.

## Indications for use
The Plexus SCD 110 DVT Sleeve is a prescription device intended to be used preventatively to increase venous blood flow in patients at risk of deep vein thrombosis due to the associated risk factors for thrombus formation during: trauma, critical care, general medicine, general surgery, as well as neurological, orthopedic, urologic, obstetric conditions and treatments.

Source page: https://510kreport.com/device/K190975
Methodology: https://510kreport.com/methodology