510(k) Report

FDA applicant

Vital Signs, Inc., A GE Healthcare Company

Totowa, NJ2 decisions2012–20132 recalls

FDA records 2 decisions for Vital Signs, Inc., A GE Healthcare Company (Totowa, NJ) from 2012 to 2013: 2 510(k) clearances. All are in product code LGZ (Warmer, Thermal, Infusion Fluid). Its devices cite 2 predicates, 1 of them its own earlier devices. 2 recalls are linked to its devices, 2 Class I.

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 Vital Signs, Inc., A GE Healthcare Company’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2012: 12013: 1
2012high 1 (2012) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

2in 2019

2019: 2, 2 Class I
2012high 2 (2019) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Vital Signs, Inc., A GE Healthcare Company by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LGZWarmer, Thermal, Infusion Fluid2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K121775Enflow IV Fluid Warmer, Enflow Disposable Cartridge, Enflow ControllerVital Signs, Inc., A GE Healthcare Company · 20121cites it

What has FDA decided for it lately?

  • K130867Enflow IV Fluid Warmer Insulated StrapVital Signs, Inc., A GE Healthcare Company · 20132 Class I recalls
  • K121775Enflow IV Fluid Warmer, Enflow Disposable Cartridge, Enflow ControllerVital Signs, Inc., A GE Healthcare Company · 2012

All 2 as Vital Signs, Inc., A GE Healthcare Company →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K130867enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood…Mar 13, 2019Class I
  • K130867enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy…Mar 13, 2019Class I

Other applicant names beginning “Vital”

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

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