510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K141869Substantially Equivalent

Qflow 500 Titanium Bolt, Quad Lumen Bolt Kit

Hemedex Incorporated, Cambridge MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K141869 is the FDA 510(k) clearance record for QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT, a class II device, cleared for Hemedex Incorporated on under FDA product code GWM (Device, Monitoring, Intracranial Pressure). FDA records list 4 510(k) clearances for Hemedex Incorporated, from to . As of , FDA records show no recalls naming K141869.

Clearance record

Decision date
Received
(91 days to decision)
Product code
GWM Device, Monitoring, Intracranial Pressure
Regulation
21 CFR 882.1620
Device class
Class II
Review panel
Neurology
Applicant
Hemedex Incorporated 222 3rd St. Suite 0123, Cambridge MA
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