FDA applicant

Haemotronic, Inc.

Fairfield, NJ6 decisions1992–20210 recalls

FDA records 6 decisions for Haemotronic, Inc. (Fairfield, NJ) from 1992 to 2021: 6 510(k) clearances. Most are in product codes KPE (Container, I.V.) and FPA (Set, Administration, Intravascular). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Haemotronic S.P.A.”.

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 Haemotronic, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2007high 1 (2020) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Haemotronic, Inc.’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

Haemotronic, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?