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
K241385Substantially Equivalent

Omnifix Syringe NRFit

B.Braun Medical, Inc., Bethlehem PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K241385 is the FDA 510(k) clearance record for Omnifix Syringe NRFit, a class II device, cleared for B.Braun Medical, Inc. on under FDA product code QEH (Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact). FDA's definition for product code QEH reads: "A neuraxial piston syringe is intended to inject or withdraw fluid from the neuraxial space with neuraxial specific connections. This product code may include epidural, peripheral, subarachnoid/spinal block, intrathecal and/or...". FDA records list 149 510(k) clearances for B.Braun Medical, Inc., from to . As of , FDA records show no recalls naming K241385.

Clearance record

Decision date
Received
(59 days to decision)
Product code
QEH Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Applicant
B.Braun Medical, Inc. 824 Twelfth Ave., Bethlehem PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QEH

Trailing 12 months

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

FDA records show no clearances under product code QEH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QEH, 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