510(k) Report

FDA applicant

K-Systems, Kivex Biotec, Ltd.

Birkerod, DK1 decision2001–20010 recalls

FDA records 1 decision for K-Systems, Kivex Biotec, Ltd. (Birkerod, DK) in 2001: 1 510(k) clearance. All are in product code MQG (Accessory, Assisted Reproduction). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided K-Systems, Kivex Biotec, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for K-Systems, Kivex Biotec, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — K-Systems, Kivex Biotec, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like K-Systems, Kivex Biotec, 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?

  • MQGAccessory, Assisted Reproduction1decision

What has FDA decided for it lately?

  • K013401K-Systems Culture Bag Sealer and Culture Bags Type CBS-1 and CB-01K-Systems, Kivex Biotec, Ltd. · 2001

The one decision as K-Systems, Kivex Biotec, Ltd. →