Cleared Traditional

K190795 - Tetragraph Neuromuscular Transmission M...

K190795 is an FDA 510(k) clearance for Tetragraph Neuromuscular Transmission M..., manufactured by Senzime AB. The device is a Class 2 Anesthesiology device with product code KOI cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K190795 · Senzime AB · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2019
Decision
204d
Days
Class 2
Risk

K190795 is an FDA 510(k) clearance for the Tetragraph Neuromuscular Transmission Monitor. Classified as Stimulator, Nerve, Peripheral, Electric (product code KOI), Class II - Special Controls.

Submitted by Senzime AB (Uppsala, SE). The FDA issued a Cleared decision on October 18, 2019 after a review of 204 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2775 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Senzime AB devices

FDA 510(k) Submission Details - K190795

510(k) Number K190795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2019
Decision Date October 18, 2019
Days to Decision 204 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 140d · This submission: 204d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOI Device Classification - Class 2, Special Controls

Product Code KOI Stimulator, Nerve, Peripheral, Electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2775
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Consultant

Obleix Consulting, LLC
Elisa Maldonado-Holmertz

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KOI Stimulator, Nerve, Peripheral, Electric

All 22
Devices cleared under the same product code (KOI) and FDA review panel - the closest regulatory comparables to K190795.
Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM
K213316 · Nihon Kohden Corporation · Dec 2021
Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series
K201949 · Nihon Kohden Corporation · May 2021
TwitchView System
K192958 · Blink Device Company · Apr 2020
ToFscan
K172690 · Idmed · May 2018
TwitchView System
K172843 · Blink Device Corporation · Mar 2018
DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIES
K051635 · Ge Healthcare · Jul 2005