Vital Signs, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 75
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
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.
Catalogue
Search and filter all 75 devicesShowing 1-50 of 75
FDA recalls
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.
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.
Full distribution text
- 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.
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.
Frequently asked questions
How many devices does Vital Signs, Inc. have in the registry?
The registry currently lists 75 devices for Vital Signs, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Vital Signs, Inc.'s devices?
Among its 50 most recently registered devices, Vital Signs, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Vital Signs, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Vital Signs, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Vital Signs, Inc.?
FDA recall records list 2 recalls initiated by Vital Signs, Inc., the most recent initiated on 2010-07-15. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Vital Signs, Inc. in the registry?
The most recently registered devices listed for Vital Signs, Inc. include 1.1, 1.2, 1.3 TEMPERATURE PROBES, PEDIATRIC ANESTHESIA CIRCUIT, BLOOD PRESSURE CUFFS and DOWNS CAP FLOW GENERATOR.