510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K192958Substantially Equivalent

TwitchView System

Blink Device Company, Seattle WA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K192958 is the FDA 510(k) clearance record for TwitchView System, a class II device, cleared for Blink Device Company on under FDA product code KOI (Stimulator, Nerve, Peripheral, Electric). FDA records list 2 510(k) clearances for Blink Device Company, from to . As of , FDA records show no recalls naming K192958.

Clearance record

Decision date
Received
(163 days to decision)
Product code
KOI Stimulator, Nerve, Peripheral, Electric
Regulation
21 CFR 868.2775
Device class
Class II
Review panel
Anesthesiology
Applicant
Blink Device Company 1530 Westlake Ave. N Suite 600, Seattle WA
510(k) summary
Statement
Third party review
No

Clearances, product code KOI

Trailing 12 months
1 clearance under product code KOI in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KOI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260