# K994057: Slendair 4000 Compression System

- Pathway: 510(k) (Traditional)
- Applicant: Medical Compression Systems (Dbn), Ltd.
- Decided: Mar 3, 2000 after 94 days
- Product code: IRP (Massager, Powered Inflatable Tube)
- Device class: 2
- Regulation: 21 CFR 890.5650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K915092 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915092: Talley TM300 Sequential Multicom Compression Syst, Progressive Medical Technology, Inc. (1992) Summary page 2.
- K915637: Talley TM500 Sequential Multicom Compression Syst., Progressive Medical Technology, Inc. (1992) Summary page 2.
- K914774: Multipulse Sequential Compression Unit, Talley Group, Ltd. (1992) Summary page 2.

## Indications for use
The SlendAir 4000 is a prescriptive device that induces controlled compression of the calf, the leg or the arm. The SlendAir 4000 is intended for use by medical professionals and patients at home in treating many conditions, such as: Primary lymphoedema Post mastectomy edema Leg ulcers Edema following trauma and sport injuries Post immobilization edema Venous insufficiencies Lymphoedema

Source page: https://510kreport.com/device/K994057
Methodology: https://510kreport.com/methodology