Cleared Traditional

K220530 - Tetragraph Neuromuscular Transmission M...

K220530 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 174-day FDA review.

K220530 · Senzime AB · Anesthesiology device
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Aug 2022
Decision
174d
Days
Class 2
Risk

K220530 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 August 17, 2022 after a review of 174 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 - K220530

510(k) Number K220530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2022
Decision Date August 17, 2022
Days to Decision 174 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
34d slower than avg
Panel avg: 140d · This submission: 174d
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

Obelix Consulting
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
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