Cleared Special

nextaro® v, 20/20 (K240748) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K240748 · Sfm Medical Devices GmbH · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2024
Decision
28d
Days
Class 2
Risk

K240748 is an FDA 510(k) clearance for the nextaro® v, 20/20. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Sfm Medical Devices GmbH (Waechtersbach, DE). The FDA issued a Cleared decision on April 16, 2024 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sfm Medical Devices GmbH devices

Submission Details

510(k) Number K240748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2024
Decision Date April 16, 2024
Days to Decision 28 days
Submission Type Special
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
101d faster than avg
Panel avg: 129d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LHI Set, I.v. Fluid Transfer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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.

Regulatory Peers - LHI Set, I.v. Fluid Transfer

All 64
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K240748.
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Mix2Vial® Transfer Device
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Vial Adapter 20mm
K232875 · West Pharma Services Il, Ltd. · Dec 2023