# K142728: ActiveCare+SFT; ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category), ActiveCare+DTx ; ActiveCare+DTx HomeCare (ActiveCare+DTx-sub-category)

- Pathway: 510(k) (Traditional)
- Applicant: Medical Compressions System (Dbn), Ltd.
- Decided: Dec 4, 2014 after 72 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: 6 generations back to K944567 (1995). 30 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140755: Activecare DVT, Activecare+SFT, and Activecare+DTX Systems, Medical Compression Systems (Dbn), Ltd. (2014) Summary page 4.
- K133274: Vena Pro, Innovamed Health, LLC (2014) Summary page 4.
- K102737: Kendall SCD 700 Sequential Compression Controller, Covidien, LLC (2010) Summary page 4.
- K141609: Pulstar Logix Pump, Albahealth, LLC (2014) Summary page 4.

## Most influential descendants
- K151377: ActiveCare+SFT;ActiveCare+SFT HomeCare, ActiveCare+DTx;ActiveCare+DTx HomeCare (2015), 1 descendant of its own
- K160431: ActiveCare Home (2016), 0 descendants of its own

## Indications for use
The ActiveCare+S.F.T. and ActiveCare+DTx Systems are portable, ambulatory, sequential, intermittent pneumatic compression devices (IPCDs) prescribed by health care professionals. The systems include a rechargeable battery powered option allowing patient mobility and ease of use. These devices simulate muscle contractions in order to treat or enhance blood flow velocity in individuals experiencing venous impairment or reduced pulsatility (dysfunction of the muscle pump) when blood flow may become challenged or compromised, such as during and after major orthopedic surgery procedures e.g total joint (hip and knee) arthroplasty. They are intended for use in the clinical setting or home environment. These devices are indicated for use in: Preventing Deep Vein Thrombosis (DVT) Diminishing post-operative pain and swelling Reducing wound healing time Patients at risk for deep vein thrombosis (DVT) and related pulmonary embolism (PE) (Venous Thromboembolism (VTE)) Treatment of venous stasis Treatment and assistance in healing: Stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers Enhancing blood circulation Treatment of chronic venous insufficiency Reducing edema The ActiveCare+S.F.T. and ActiveCare+DTx Systems are intended to provide external compression in synchrony with the specific patient’s natural venous blood flow return profile in order to achieve a high pulsatile venous blood flow. In addition, the ActiveCare+DTx System can detect hemodynamic changes in venous blood flow.

Source page: https://510kreport.com/device/K142728
Methodology: https://510kreport.com/methodology