FDA applicant

Vital Diagnostics (Manufacturing) Ptyltd

Noble Park, AU5 decisions2010–20122 recalls

FDA records 5 decisions for Vital Diagnostics (Manufacturing) Ptyltd (Noble Park, AU) from 2010 to 2012: 5 510(k) clearances. Most are in product codes KHS (Enzymatic, Carbon-Dioxide) and JIX (Calibrator, Multi-Analyte Mixture). 2 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, clinical chemistry panel, where it files most

How often FDA has decided Vital Diagnostics (Manufacturing) Ptyltd’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2010high 3 (2011) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

2in 2013

2010high 2 (2013) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Vital Diagnostics (Manufacturing) Ptyltd by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Vital Diagnostics (Manufacturing) Ptyltd’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 Scientific N.V. 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 Diagnostics (Manufacturing) Ptyltd

Which product codes does it file in?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Vital”