510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K896834Substantially Equivalent

Model Bt-1 Fot Bolt Installation Kit

Pearl Instruments Corp., Highland Park IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K896834 is the FDA 510(k) clearance record for MODEL BT-1 FOT BOLT INSTALLATION KIT, a class II device, cleared for Pearl Instruments Corp. on under FDA product code GWM (Device, Monitoring, Intracranial Pressure). FDA records list 2 510(k) clearances for Pearl Instruments Corp., from to . As of , FDA records show no recalls naming K896834.

Clearance record

Decision date
Received
(80 days to decision)
Product code
GWM Device, Monitoring, Intracranial Pressure
Regulation
21 CFR 882.1620
Device class
Class II
Review panel
Neurology
Applicant
Pearl Instruments Corp. 3382 Dato Ave., Highland Park IL
Third party review
No

Clearances, product code GWM

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