T4 Monitor Stimulator Computer

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K853476 ↗

FDA Product Code

BXN

Device Class

Class II

Regulation

21 CFR Part 868.2775

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• The Gripper

  Class II

  FDA 510(k) K853422 Active Cleared 15 Jan 1986

• Nerve Finder

  Class II

  FDA 510(k) K853477 Active Cleared 14 Jan 1986

• Pinpoint Needle

  Class II

  FDA 510(k) K853478 Active Cleared 15 Jan 1986

• What is the T4 Monitor Stimulator Computer used for?

  The T4 Monitor Stimulator Computer is designed to assess neuromuscular blockade during anesthesia. It delivers controlled electrical stimuli to peripheral nerves, allowing clinicians to evaluate the functional response of skeletal muscles. This helps in accurately titrating neuromuscular blocking agents, ensuring optimal patient outcomes in operating rooms and anesthesia care settings.

• Is the T4 Monitor Stimulator Computer single-use or reusable?

  The T4 Monitor Stimulator Computer is supplied as a reusable medical instrument. There is no indication in the available records that it requires sterilization or is intended for single-use, making it suitable for repeated use in clinical settings.

• What regulatory approval does the T4 Monitor Stimulator Computer hold?

  The device holds FDA 510(k) clearance under the reference number K853476. It is classified as a Class II medical device under product code BXN, with a decision of substantial equivalence in the Anesthesiology advisory committee. This clearance confirms its compliance with regulatory standards for nerve stimulators.

• Can the T4 Monitor Stimulator Computer be used with MRI equipment?

  The available records do not provide MRI safety data for the T4 Monitor Stimulator Computer. Clinicians should verify compatibility with their specific MRI systems before use to ensure patient safety and avoid interference.

• What types of electrical stimuli does the T4 Monitor Stimulator Computer deliver?

  While the exact specifications of the electrical stimuli (e.g., frequency, amplitude) are not detailed in the provided data, the device is designed to deliver controlled electrical stimuli to peripheral nerves. This functionality aids in assessing neuromuscular responses, which is critical for monitoring the effects of neuromuscular blocking agents during anesthesia.