Cleared Traditional

K952435 - CELSITE PEDIATRIC VENOUS SYSTEM

K952435 is the FDA 510(k) clearance for CELSITE PEDIATRIC VENOUS SYSTEM by B.Braun Medical, Inc.. It is a Class 2 General Hospital device (product code LJT) cleared through the Traditional 510(k) pathway after a 329-day FDA review.

K952435 · B.Braun Medical, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Apr 1996
Decision
329d
Days
Class 2
Risk

K952435 is an FDA 510(k) clearance for the CELSITE PEDIATRIC VENOUS SYSTEM. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by B.Braun Medical, Inc. (Melsungen, DE). The FDA issued a Cleared decision on April 17, 1996 after a review of 329 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5965 - 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. Elevated predicate reliance profile. 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 Medical, Inc. devices

Submission Details

510(k) Number K952435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1995
Decision Date April 17, 1996
Days to Decision 329 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
200d slower than avg
Panel avg: 129d · This submission: 329d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5965
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 - LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

All 109
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K952435.
LOW PROFILE PLASTIC PORT DETACHED CATHETER SYSTEM CATALOG #1017
K961652 · Arrow Intl., Inc. · Jul 1996
A PORT DETACHED CATHETER SYSTEM CATALOG #1002
K961583 · Arrow Intl., Inc. · Jul 1996
THEREX LOW PROFILE B PORT 1.0MM I.D./1.8MM O.D. DETACHED CATHETER
K960572 · Arrow Intl., Inc. · Apr 1996
VASCULAR ACCESS PORT KIT
K955587 · Boston Scientific Corp · Mar 1996
A2 DETACHED DUAL PORT SYSTEM
K955819 · Arrow Intl., Inc. · Mar 1996
CELSITE VENOUS ACCESS SYSTEM OTW
K954297 · B.Braun Medical, Inc. · Dec 1995