510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912139Substantially Equivalent

Model 704

Ivy Biomedical Systems, Inc., Branford CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912139 is the FDA 510(k) clearance record for MODEL 704, a class II device, cleared for Ivy Biomedical Systems, Inc. on under FDA product code GWM (Device, Monitoring, Intracranial Pressure). FDA records list 27 510(k) clearances for Ivy Biomedical Systems, Inc., from to . As of , FDA records show no recalls naming K912139.

Clearance record

Decision date
Received
(316 days to decision)
Product code
GWM Device, Monitoring, Intracranial Pressure
Regulation
21 CFR 882.1620
Device class
Class II
Review panel
Neurology
Applicant
Ivy Biomedical Systems, Inc. 11 Business Park Dr., Branford CT
510(k) summary
Statement
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