Cleared Traditional

K152050 - Pencylcap

K152050 is an FDA 510(k) clearance for Pencylcap, manufactured by B.Braun Melsungen AG. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K152050 · B.Braun Melsungen AG · General Hospital
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Mar 2016
Decision
223d
Days
Class 2
Risk

K152050 is an FDA 510(k) clearance for the Pencylcap. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by B.Braun Melsungen AG (Melsungen, DE). The FDA issued a Cleared decision on March 2, 2016 after a review of 223 days - an extended review cycle.

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

FDA 510(k) Submission Details - K152050

510(k) Number K152050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2015
Decision Date March 02, 2016
Days to Decision 223 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
94d slower than avg
Panel avg: 129d · This submission: 223d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

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 Consultant

Yes Medical Device Services GmbH
KARIN LUBBERS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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All 455
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