510(k) Report

FDA applicant

Clinico

Bad Hersfeld, DE2 decisions1997–20040 recalls

FDA records 2 decisions for Clinico (Bad Hersfeld, DE) from 1997 to 2004: 2 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and LHI (Set, I.V. Fluid Transfer). Its devices cite 1 predicate, 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, general hospital panel, where it files most

How often FDA has decided Clinico’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Clinico since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Clinico by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Clinico’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?

  • FPASet, Administration, Intravascular1decision
  • LHISet, I.V. Fluid Transfer1decision

Whose devices does it build on?

Its devices cite 1 predicate; 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.

  • K974198Taky-Spike PlusClinico · 19971cites it

What has FDA decided for it lately?

  • K041919Perfudrop Air M-P with Needle 20 G, Model 48451606Clinico · 2004
  • K974198Taky-Spike PlusClinico · 1997

All 2 as Clinico →