510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K101386Substantially Equivalent

Vigilant EEG Monitor Model Vigilant 2.0

Infinite Biomedical Technologies, LLC, Baltimore MD / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101386 is the FDA 510(k) clearance record for VIGILANT EEG MONITOR MODEL VIGILANT 2.0, a class II device, cleared for Infinite Biomedical Technologies, LLC on under FDA product code GWQ (Full-Montage Standard Electroencephalograph). FDA's definition for product code GWQ reads: "Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations". FDA records list 6 510(k) clearances for Infinite Biomedical Technologies, LLC, from to . As of , FDA records show no recalls naming K101386.

Clearance record

Decision date
Received
(73 days to decision)
Product code
GWQ Full-Montage Standard Electroencephalograph
Regulation
21 CFR 882.1400
Device class
Class II
Review panel
Neurology
Applicant
Infinite Biomedical Technologies, LLC 3600 Clipper Mill Rd., Baltimore MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GWQ

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