# K250190: Sequential Compression System (SCD600)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Comen Medical Instruments Co.,Ltd
- Decided: Dec 8, 2025 after 319 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 K953648 (1996). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120944: Kendall SCD 700 Sequential Compression Controller, Covidien (2012) Summary page 5.

## Indications for use
The SCD600 Sequential Compression System (hereby referenced as "SCD600") is designed to increase the flow rate of the patient's venous blood in order to prevent deep vein thrombosis and pulmonary embolism and treat limb edema via intermittent pneumatic compression. The SCD600 is intended for use only in professional healthcare facilities by medical staff as part of a prescribed plan of care.

Source page: https://510kreport.com/device/K250190
Methodology: https://510kreport.com/methodology