Tetragraph Neuromuscular Transmission Monitor
510(k) K220530
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK220530 | Date17 Aug 2022 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 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, 18 Sep 2026
The Tetragraph Neuromuscular Transmission Monitor is a Stimulator, Nerve, Peripheral, Electric designed to assess neuromuscular function by measuring peripheral nerve responses. It provides real-time monitoring of neuromuscular transmission, enabling precise evaluation of muscle relaxation and recovery during anesthesia or critical care procedures.
This device is intended for use in clinical settings such as operating rooms and intensive care units, where neuromuscular blockade is managed. Supplied as a reusable medical device, it adheres to FDA 510(k) and MDR regulatory standards. The monitor operates within the constraints of Class II medical device classification under 21 CFR 868.2775, ensuring compliance with safety and performance requirements for peripheral nerve stimulators.
Other devices from Senzime AB
Questions
AI-generated answers, 18 Sep 2026
What clinical settings is the Tetragraph Neuromuscular Transmission Monitor primarily designed for, and why?
The Tetragraph is designed for use in operating rooms and intensive care units, where neuromuscular blockade is actively managed. This is because it provides real-time monitoring of neuromuscular transmission, which is critical during anesthesia procedures and in critical care to assess muscle relaxation and recovery accurately.
Is the Tetragraph Neuromuscular Transmission Monitor a single-use or reusable device, and how does this affect its use?
The Tetragraph is supplied as a reusable medical device. This means it can be cleaned, disinfected, and used multiple times across different patients, provided proper maintenance protocols are followed. Reusability helps reduce waste and costs while ensuring consistent performance for ongoing clinical monitoring.
What regulatory pathways has the Tetragraph Neuromuscular Transmission Monitor followed, and what does this imply for its safety and performance?
The device has undergone FDA 510(k) clearance and MDR (Medical Device Regulation) authorization, both of which are rigorous pathways ensuring compliance with safety and performance standards. The classification under 21 CFR 868.2775 as a Class II device further confirms it meets stringent requirements for peripheral nerve stimulators, including design controls, labeling, and manufacturing practices.
How does the Tetragraph’s real-time monitoring capability benefit clinicians during procedures?
The Tetragraph’s real-time monitoring of neuromuscular transmission allows clinicians to precisely evaluate muscle relaxation and recovery during anesthesia or critical care. This ensures accurate dosing of neuromuscular blocking agents, reduces the risk of residual blockade, and improves patient safety by enabling timely adjustments to treatment plans.
What specialties or clinical teams would primarily use the Tetragraph, and why is it relevant to them?
The device is specifically relevant to anesthesiologists, as indicated by its Anesthesiology advisory committee designation and medical specialty classification. It aids in managing neuromuscular blockade, which is a core aspect of anesthesia practice, ensuring optimal muscle relaxation and recovery during surgical procedures or intensive care interventions.