510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K090957Substantially Equivalent

Blackrock Neuroport Biopotential Signal Processing System

Blackrock Microsystems, Stoughton WI / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K090957 is the FDA 510(k) clearance record for BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM, a class II device, cleared for I2s Micro Implantable Systems, LLC on under FDA product code GWL (Amplifier, Physiological Signal). FDA records list 4 510(k) clearances for Blackrock Microsystems, from to . As of , FDA records show 2 recalls naming K090957.

Clearance record

Decision date
Received
(52 days to decision)
Product code
GWL Amplifier, Physiological Signal
Regulation
21 CFR 882.1835
Device class
Class II
Review panel
Neurology
Applicant
I2s Micro Implantable Systems, LLC 800 Levanger Ln., Stoughton WI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GWL

Trailing 12 months

FDA records hold no clearances under product code GWL in the trailing twelve months.

FDA records show no clearances under product code GWL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GWL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260