FDA applicant

Vital Signs, Inc.

Totowa, NJ75 decisions1979–20122 recalls

FDA records 75 decisions for Vital Signs, Inc. (Totowa, NJ) from 1979 to 2012: 75 510(k) clearances. Most are in product codes BTM (Ventilator, Emergency, Manual (Resuscitator)) and BYE (Attachment, Breathing, Positive End Expiratory…). Its devices cite 14 predicates, 2 of them its own earlier devices. 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, anesthesiology panel, where it files most

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

FDA decisions per year

1in 2012

2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2013

2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Vital Signs, 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

Other applicant names beginning “Vital”

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

Vital Images, Inc. 41 Vital Metrics, Inc. 9 Vital Scientific N.V. 5 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 Signs, 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?

What has been recalled?

Other applicant names beginning “Vital”