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Vital Signs, Inc.

United StatesFDA applicant, unverified

Devices
75
FDA recalls
2

What Vital Signs, Inc. makes

Vital Signs, Inc. manufactures single-use and disposable medical devices for anesthesia, respiratory care, and patient monitoring, including pediatric anesthesia circuits, blood pressure cuffs, and airway management tools like laryngoscope blades and tracheal tubes. Their portfolio also includes fluid warmers, breathing circuit components, and specialized respiratory devices such as a one-lung CPAP system and humidifiers. Non-conductive face masks and airway adjuncts like the Berman airway are also part of their offerings.

The company’s devices are regulated under the FDA’s 510(k) pathway, with products classified as Class I and Class II. These devices are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. The manufacturer operates from the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue75

Newest first, rows 51-75 of 75

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  • Telemetric Stethoscope Ref K882319

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Esophogral Multiprobe Ref K832903

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Connecting Tube Ref K951745

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Intercept Ref K843591

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Meconium Suction Device (Msd) Ref K914370

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Peep Valve Ref K820404

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Posivac Ref K791127

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vital Signs Saline Vascular Access Flush Device Ref K952645

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Adult Circle Breath Circuit W/Intern Gas Samp Line Ref K905450

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Sure-Lok Ref K021315

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Piggyback Breathing Circuit Ref K791034

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Single Use Non-Conductive Circ. Discon Ref K821667

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vital Signs Heparin Vascular Access Flush Device Ref K953120

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Breas Pv 10I Cpap System, Model Pv 10I Ref K030985

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Resuscitation Circuit Ref K812273

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vital Signs Peep Valve Ref K802070

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Downs Adjustable Flow Generator Ref K831503

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Manual Resuscitator Ref K910856

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vital Pak Ref K955417

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Breathe Easy Ref K914336

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Bodyguard Ref K000441

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Xenon Delivery System Ref K820143

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Compact Mask Ref K932347

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Endotracheal Cpap Set Ref K915277

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Flex-Elbow Ref K912652

    Active Regimes: 510(k) Registry: 510(k) Class:I

Rows 51-75 of 75

Showing 51-75 of 75

FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 2 recalls initiated by Vital Signs, Inc., the earliest on 2009-06-30 and the most recent on 2010-07-15. By recorded status: 2 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2010

    • 15 Jul 2010 Z-2380-2010 Unclassified (pre-2012) Terminated The enFlow Disposable IV Fluid/Blood Warmer Cartridge's male luer-lock fitting may be oversized and may not fit properly with standard female luer fittings. Distribution: Worldwide Distribution; USA (all states), and to the countries of Australia, Ecuador, Finland, India, Israel, Latvia,…
      Full distribution text Worldwide Distribution; USA (all states), and to the countries of Australia, Ecuador, Finland, India, Israel, Latvia, Lebanon, Malaysia, Mexico, Morocco, New Zealand, Panama, Philippines, Qatar, Saudi Arabia, Singapore, Switzerland, the Netherlands, and Vietnam.
      Submission number: K060537

  • 2009

    • 30 Jun 2009 Z-1912-2009 Unclassified (pre-2012) Terminated Not compatible: The luer connector on the Intraosseus needle provided does not fit securely on the luer connection of the IV Extension Set in the module. Distribution: Worldwide Distribution -- US, Canada, United Arab Emirate, Venezuela, Guam, Korea and United Kingdom.