510(k) Report

FDA applicant

Medical Compressions System (Dbn), Ltd.

Or Akiva, IL1 decision2014–20140 recalls

FDA records 1 decision for Medical Compressions System (Dbn), Ltd. (Or Akiva, IL) in 2014: 1 510(k) clearance. All are in product code JOW (Sleeve, Limb, Compressible). Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Medical Compressions System (Dbn), Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2014: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Medical Compressions System (Dbn), Ltd. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medical Compressions System (Dbn), Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • JOWSleeve, Limb, Compressible1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K142728ActiveCare+SFT; ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category), ActiveCare+DTx ; ActiveCare+DTx…Medical Compressions System (Dbn), Ltd. · 20141cites it

What has FDA decided for it lately?

  • K142728ActiveCare+SFT; ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category), ActiveCare+DTx ; ActiveCare+DTx…Medical Compressions System (Dbn), Ltd. · 2014

The one decision as Medical Compressions System (Dbn), Ltd. →