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Tetragraph Neuromuscular Transmission Monitor

by Senzime AB 2 variants

510(k) K190795

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK190795 Date18 Oct 2019ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KOI
Device Class
Class II
Regulation
21 CFR Part 868.2775
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Tetragraph Neuromuscular Transmission Monitor is a peripheral nerve stimulator device used to assess neuromuscular transmission. It is classified as a Class II medical device under FDA regulation 868.2775 and is substantially equivalent to a predicate device.

The device is supplied by Senzime AB and was cleared via the traditional 510(k) pathway under K190795. It is intended for use in anesthesiology settings and has been reviewed by the Anesthesiology advisory committee. The device is non-sterile and reusable, with no MRI safety information provided in the data.

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Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Tetragraph Neuromuscular Transmission Monitor used for?

    The Tetragraph Neuromuscular Transmission Monitor is used to assess neuromuscular transmission by stimulating peripheral nerves, helping clinicians evaluate the depth of neuromuscular blockade during anesthesia.

  • Is the Tetragraph Neuromuscular Transmission Monitor sterile or non-sterile, and is it intended for single use or reuse?

    The device is non-sterile and designed for reuse, meaning it can be cleaned and used multiple times following the manufacturer's instructions, as no single-use labeling or sterility claims are provided in the data.

  • How was the Tetragraph Neuromuscular Transmission Monitor cleared for market, and what is its regulatory classification?

    The device was cleared via the traditional 510(k) pathway under K190795 and is classified as a Class II medical device under FDA regulation 868.2775, based on substantial equivalence to a predicate device.