510(k) Report

FDA applicant

Sfm Medical Devices GmbH

Waechtersbach, DE3 decisions2019–20240 recalls

FDA records 3 decisions for Sfm Medical Devices GmbH (Waechtersbach, DE) from 2019 to 2024: 3 510(k) clearances. All are in product code LHI (Set, I.V. Fluid Transfer). Since 2016 its 510(k)s took a median of 63 days from receipt to decision, against 166 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 2 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, general hospital panel, where it files most

How often FDA has decided Sfm Medical Devices GmbH’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2019: 12024: 2
2019high 2 (2024) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Sfm Medical Devices GmbH by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sfm Medical Devices GmbH’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?

  • LHISet, I.V. Fluid Transfer3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 63 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 166 days; 3 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K183187nextaro Transfer System, nextaro vaSfm Medical Devices GmbH · 20192cite it

What has FDA decided for it lately?

  • K241976nextaro® va, 15mm, 5µmSfm Medical Devices GmbH · 2024
  • K240748nextaro® v, 20/20Sfm Medical Devices GmbH · 2024
  • K183187nextaro Transfer System, nextaro vaSfm Medical Devices GmbH · 2019

All 3 as Sfm Medical Devices GmbH →