Cleared Traditional

K241385 - Omnifix Syringe NRFit (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K241385 · B.Braun Medical, Inc. · General Hospital
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Jul 2024
Decision
59d
Days
Class 2
Risk

K241385 is an FDA 510(k) clearance for the Omnifix Syringe NRFit. Classified as Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/or Indirect Cerebral Spinal Fluid Contact (product code QEH), Class II - Special Controls.

Submitted by B.Braun Medical, Inc. (Bethlehem, US). The FDA issued a Cleared decision on July 13, 2024 after a review of 59 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all B.Braun Medical, Inc. devices

Submission Details

510(k) Number K241385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2024
Decision Date July 13, 2024
Days to Decision 59 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 128d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QEH Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/or Indirect Cerebral Spinal Fluid Contact
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
Definition 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 Intracerebroventricular Administration Routes. The Connector For Neuraxial Applications Is Intended To Facilitate Ansi/aami/iso 80369-6:2016 Compliant Neuraxial Specific Connections.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.