510(k) Report

FDA applicant

Pentaferte S.P.A

Campli (Teramo), IT3 decisions2001–20050 recalls

FDA records 3 decisions for Pentaferte S.P.A (Campli (Teramo), IT) from 2001 to 2005: 3 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and FMF (Syringe, Piston). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Pentaferte, S.R.L.”.

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 Pentaferte S.P.A’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pentaferte S.P.A since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Pentaferte S.P.A’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
  • FMFSyringe, Piston1decision
  • BRZSet, Blood Transfusion1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K002381Pentaferte Single Use Syringes, Model Size=Various SizesPentaferte, S.R.L. · 20011cites it
  • K041496Pentatrasfu Blood Transfusion SetsPentaferte S.P.A · 20051cites it

What has FDA decided for it lately?

  • K041496Pentatrasfu Blood Transfusion SetsPentaferte S.P.A · 2005
  • K041495Pentadeflue IV Solution Administration SetsPentaferte S.P.A · 2005
  • K002381Pentaferte Single Use Syringes, Model Size=Various SizesPentaferte, S.R.L. · 2001

All 2 as Pentaferte S.P.A →The one decision as Pentaferte, S.R.L. →

Other applicant names beginning “Pentaferte”

FDA records each applicant name separately; these may or may not be the same firm.

Pentaferte Italia S.R.L. 3