Cleared Traditional

K112636 - CYTOGUARD(TM) CLOSED LUER CONNECTOR

K112636 is an FDA 510(k) clearance for CYTOGUARD(TM) CLOSED LUER CONNECTOR, manufactured by B.Braun Medical, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K112636 · B.Braun Medical, Inc. · General Hospital
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Nov 2011
Decision
78d
Days
Class 2
Risk

K112636 is an FDA 510(k) clearance for the CYTOGUARD(TM) CLOSED LUER CONNECTOR. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on November 26, 2011 after a review of 78 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. 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

FDA 510(k) Submission Details - K112636

510(k) Number K112636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2011
Decision Date November 26, 2011
Days to Decision 78 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
51d faster than avg
Panel avg: 129d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
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 - FPA Set, Administration, Intravascular

All 721
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