# K101355: Augease Vascular Augmentation Device

- Pathway: 510(k) (Traditional)
- Applicant: Augdvt, LLC
- Decided: Oct 26, 2010 after 165 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: 1 generation back to K903894 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903894: Venapulse Models VP-25 and VP-50, Aci Medical, Inc. (1991) Summary page 3.

## Indications for use
The AugEase™ is a foot actuated augmentation device intended to rapidly inflate and deflate an air bladder cuff generating static, tourniquet pressure to limbs of patients undergoing vascular testing. It is indicated as an accessory to an ultrasound imaging machine with or without Doppler which may be used for: Distal augmentations Proximal augmentations Reflux measurements of specific venous valves Vein Mapping Locating suitable distal vessel for bypass Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K101355
Methodology: https://510kreport.com/methodology