VitalMax 4100

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K953795 ↗

FDA Product Code

CBS

Device Class

Class II

Regulation

21 CFR Part 868.1620

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Vitalmax 4000

  Class II

  FDA 510(k) K933624 Active Cleared 19 Jul 1994

• Vitalmax 830 Series

  Class II

  FDA 510(k) K913263 Active Cleared 10 Oct 1991

• Oximax 700

  Class II

  FDA 510(k) K900866 Active Cleared 4 Apr 1990

• Minipack 911-Stc

  Class II

  FDA 510(k) K925701 Active Cleared 11 Aug 1994

• Handypack 911SC

  Class II

  FDA 510(k) K944541 Active Cleared 22 Feb 1995

• Vitalmax 800-C

  Class II

  FDA 510(k) K930559 Active Cleared 3 Sep 1993

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• What is the VitalMax 4100 used for?

  The VitalMax 4100 is designed to measure halothane concentration in inhaled anesthetic mixtures. This gaseous-phase anesthetic gas analyzer helps clinicians monitor volatile anesthetic agents during surgical and emergency procedures, ensuring accurate delivery and enhancing patient safety by preventing overdosing or underdosing.

• Is the VitalMax 4100 a single-use or reusable device?

  The VitalMax 4100 is a reusable medical instrument. It is intended for repeated use in clinical settings such as operating rooms and intensive care units, provided it is properly calibrated and maintained according to the manufacturer’s guidelines.

• Where can the VitalMax 4100 be used?

  This device is intended for use in non-MRI environments, such as operating rooms and intensive care units. Its design ensures reliable monitoring of halothane concentrations in anesthetic mixtures, making it suitable for surgical and emergency procedures where precise anesthetic delivery is critical.

• Does the VitalMax 4100 require any special storage or maintenance?

  The VitalMax 4100 must be calibrated and maintained per the manufacturer’s guidelines to ensure accurate and reliable performance. Proper storage conditions should also be followed to preserve its functionality, though specific storage instructions are not detailed in the provided data.

• What regulatory approval does the VitalMax 4100 hold?

  The VitalMax 4100 holds an FDA 510(k) clearance (K953795) and is classified as a Class II device under FDA regulations. It is regulated under the U.S. Code of Federal Regulations (CFR) Title 21, Part 868.1620 for anesthetic gas analyzers, ensuring it meets stringent safety and performance standards.