# K251466: VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System  (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System  (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System  (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System  (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr

- Pathway: 510(k) (Special)
- Applicant: Wellell, Inc.
- Decided: Oct 28, 2025 after 168 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: 5 generations back to K953648 (1996). 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)
- K213577: VenAir, Sequential Compression System, Apex Medical Corp. (2022) Summary page 5.

## Indications for use
The intended use of the VenAir Sequential Compression System (hereby referenced as "VenAir system") is to help prevent Deep Vein Thrombosis (DVT) and pulmonary embolism. The garments are single patient use - do not reuse. The VenAir system is intended for use only in professional healthcare facility environment by trained medical staff. It is not for use in the home healthcare environment. The VenAir system should be used as part of a prescribed plan of care.

Source page: https://510kreport.com/device/K251466
Methodology: https://510kreport.com/methodology