Cleared Special

K994111 - CELSITE

K994111 is an FDA 510(k) clearance for CELSITE, manufactured by B. Braun/Mcgaw. The device is a Class 2 General Hospital device with product code LJT cleared through the Special 510(k) pathway after a 28-day FDA review.

K994111 · B. Braun/Mcgaw · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
28d
Days
Class 2
Risk

K994111 is an FDA 510(k) clearance for the CELSITE, MODELS ST401L, ST405L. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by B. Braun/Mcgaw (Allentown, US). The FDA issued a Cleared decision on January 3, 2000 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 880.5965 - 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 B. Braun/Mcgaw devices

FDA 510(k) Submission Details - K994111

510(k) Number K994111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1999
Decision Date January 03, 2000
Days to Decision 28 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 129d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

LJT Device Classification - Class 2, Special Controls

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 126
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K994111.
TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTION
K003006 · Arrow Intl., Inc. · Oct 2000
IBIS CHEMO-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM, MODEL 700-08-10,700-08-11,700-08-12,700-08-15,700-08-16,735-08-10
K002770 · Hdc Corp. · Sep 2000
PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM
K994216 · Sims Deltec, Inc. · Jan 2000
PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEM
K992697 · Sims Deltec, Inc. · Nov 1999
P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM
K992880 · Sims Deltec, Inc. · Oct 1999
VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEM
K982888 · Boston Scientific Corp · Oct 1998