Cleared Traditional

K851293 - IMPLANTOFIX

K851293 is an FDA 510(k) clearance for IMPLANTOFIX, manufactured by Burron Medical Products, Inc.. The device is a Class 2 General Hospital device with product code LJT cleared through the Traditional 510(k) pathway after a 283-day FDA review.

K851293 · Burron Medical Products, Inc. · General Hospital
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Jan 1986
Decision
283d
Days
Class 2
Risk

K851293 is an FDA 510(k) clearance for the IMPLANTOFIX. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Burron Medical Products, Inc. (Bethlehem, US). The FDA issued a Cleared decision on January 9, 1986 after a review of 283 days - an extended review cycle.

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. 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 Burron Medical Products, Inc. devices

FDA 510(k) Submission Details - K851293

510(k) Number K851293 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1985
Decision Date January 09, 1986
Days to Decision 283 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
154d slower than avg
Panel avg: 129d · This submission: 283d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 215
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K851293.
HICKMAN SUBCUTANEOUS PORT W/PRE-ATTACHED CATHETER
K863305 · C.R. Bard, Inc. · Oct 1986
HDC CHEMO-PORT (VASCULAR)
K853332 · Hdc Corp. · Jul 1986
MEDTRONIC MODEL 8501 ACCESS PORT
K861498 · Medtronic Vascular · Jun 1986
MEDTRONIC ACCESS PORT MODEL 8500
K853322 · Medtronic Vascular · Nov 1985
VASCULAR-ACCESS-PORT WITHDRAWL-BLOOD
K841679 · Norfolk Medical Products, Inc. · Jun 1984
VASCULAR ACCESS PORT CHANGES IN MATER
K840788 · Norfolk Medical Products, Inc. · Apr 1984