FDA applicant

Vital Scientific N.V.

Newton, MA5 decisions1998–20025 recalls

FDA records 5 decisions for Vital Scientific N.V. (Newton, MA) from 1998 to 2002: 5 510(k) clearances. Most are in product codes KQG (Instrument, Coagulation) and GJS (Test, Time, Prothrombin). Its devices cite 6 predicates, 0 of them its own earlier devices. 5 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, hematology panel, where it files most

How often FDA has decided Vital Scientific N.V.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Vital Scientific N.V. since 2007.

Recalls per year

1in 2018

2007high 3 (2012) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Vital Scientific N.V.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Vital”

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

Vital Signs, Inc. 75 Vital Images, Inc. 41 Vital Metrics, Inc. 9 Vital Diagnostics (Manufacturing) Ptyltd 5 Vital Concepts, Inc. 4 Vital Connections, Inc. 2 Vital Art and Science Incorporated 2 Vital Signs, Inc., A GE Healthcare Company 2 Vital Access 1 Vital Signs Colorado, Inc. 1 Vital Flow Products Corp. 1 Vital 5 1

Vital Scientific N.V.

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?

What has been recalled?

Other applicant names beginning “Vital”