DeviceClearance

Product code KOI— Anesthesiology

Tetragraph Neuromuscular Transmission Monitor

Classification name
Stimulator, Nerve, Peripheral, Electric
Device class
Class 2
Regulation
21 CFR 868.2775
Advisory panel
Anesthesiology
Total cleared
29
First cleared
Most recent

Market context for product code KOI

FDA has cleared 29 devices under product code KOI between 1984 and 2026, filed by 20 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code KOI

Recent clearances under product code KOI

Data sourced from openFDA. This site is unofficial and independent of the FDA.