Cleared Traditional

K131040 - EXTAVIPRO STERICAN 30G

K131040 is the FDA 510(k) clearance for EXTAVIPRO STERICAN 30G by B.Braun Melsungen AG. It is a Class 2 General Hospital device (product code FMI) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K131040 · B.Braun Melsungen AG · General Hospital
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Jul 2013
Decision
91d
Days
Class 2
Risk

K131040 is an FDA 510(k) clearance for the EXTAVIPRO STERICAN 30G. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by B.Braun Melsungen AG (Fredrichsdorf, DE). The FDA issued a Cleared decision on July 15, 2013 after a review of 91 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all B.Braun Melsungen AG devices

Submission Details

510(k) Number K131040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2013
Decision Date July 15, 2013
Days to Decision 91 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 129d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 - FMI Needle, Hypodermic, Single Lumen

All 236
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K131040.
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