Cleared Traditional

K953110 - LOW PROFILE TITANIUM MODEL CATALOG #1003

K953110 is an FDA 510(k) clearance for LOW PROFILE TITANIUM MODEL CATALOG #1003, manufactured by Therex Corp.. The device is a Class 2 General Hospital device with product code LJT cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K953110 · Therex Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
72d
Days
Class 2
Risk

K953110 is an FDA 510(k) clearance for the LOW PROFILE TITANIUM MODEL CATALOG #1003. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Therex Corp. (Walpole, US). The FDA issued a Cleared decision on September 13, 1995 after a review of 72 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. 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 Therex Corp. devices

FDA 510(k) Submission Details - K953110

510(k) Number K953110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1995
Decision Date September 13, 1995
Days to Decision 72 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 129d · This submission: 72d
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 166
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K953110.
VASPORT DUAL LUMEN VASCULAR ACCESS SYSTEM
K954433 · Gish Biomedical, Inc. · Nov 1995
VASPORT VASCULAR ACCESS PORT
K953571 · Gish Biomedical, Inc. · Oct 1995
LOW PROFILE TITANIUM MODEL CATALOG #1003
K953073 · Arrow Intl., Inc. · Sep 1995
LOW PROFILE TITANIUM MODEL CATALOG #1003
K953017 · Therex Corp. · Sep 1995
AUTO SUTURE* CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM**
K952748 · United States Surgical, A Division of Tyco Healthc · Aug 1995
VITAL-PORT PETIET POLYSULFONE VASCULAR ACCESS SYSTEM
K951077 · Med Institute, Inc. · Jul 1995