Cleared Traditional

K172843 - TwitchView System

K172843 is an FDA 510(k) clearance for TwitchView System, manufactured by Blink Device Corporation. The device is a Class 2 Anesthesiology device with product code KOI cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K172843 · Blink Device Corporation · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
191d
Days
Class 2
Risk

K172843 is an FDA 510(k) clearance for the TwitchView System. Classified as Stimulator, Nerve, Peripheral, Electric (product code KOI), Class II - Special Controls.

Submitted by Blink Device Corporation (Seattle, US). The FDA issued a Cleared decision on March 29, 2018 after a review of 191 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 Blink Device Corporation devices

FDA 510(k) Submission Details - K172843

510(k) Number K172843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2017
Decision Date March 29, 2018
Days to Decision 191 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
51d slower than avg
Panel avg: 140d · This submission: 191d
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 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 K172843.
TwitchView System
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