510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K172209Substantially Equivalent

Aura Icp Monitoring System

Branchpoint Technologies, Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K172209 is the FDA 510(k) clearance record for AURA ICP MONITORING SYSTEM, a class II device, cleared for Branchpoint Technologies, Inc. on under FDA product code GWM (Device, Monitoring, Intracranial Pressure). FDA records list one 510(k) clearance for Branchpoint Technologies, Inc. As of , FDA records show no recalls naming K172209.

Clearance record

Decision date
Received
(298 days to decision)
Product code
GWM Device, Monitoring, Intracranial Pressure
Regulation
21 CFR 882.1620
Device class
Class II
Review panel
Neurology
Applicant
Branchpoint Technologies, Inc. 1 Technology Dr., Suite I-811, Irvine CA
510(k) summary
Summary PDF
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