Cleared Traditional

K936012 - THEREX LOW PROFILE PORT-TITANIUM MODEL

K936012 is an FDA 510(k) clearance for THEREX LOW PROFILE PORT-TITANIUM MODEL, 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 96-day FDA review.

K936012 · Therex Corp. · General Hospital
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Mar 1994
Decision
96d
Days
Class 2
Risk

K936012 is an FDA 510(k) clearance for the THEREX LOW PROFILE PORT-TITANIUM MODEL. 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 March 22, 1994 after a review of 96 days - within the typical 510(k) review window.

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 Therex Corp. devices

FDA 510(k) Submission Details - K936012

510(k) Number K936012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1993
Decision Date March 22, 1994
Days to Decision 96 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
33d faster than avg
Panel avg: 129d · This submission: 96d
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 K936012.
IPI LOW PROFILE IMPORT
K934796 · Pudenz-Schulte Medical Research Corp. · Jul 1994
THEREX LOW-PROFILE PORT
K934792 · Therex Corp. · Mar 1994
THEREX LOW-PROFILE PORT-TITANIUM
K934802 · Therex Corp. · Mar 1994
PS MEDICAL IPI ACCESS KIT
K930206 · Pudenz-Schulte Medical Research Corp. · Feb 1994
THEREX LOW-PROFILE PORT DETACHED CATHETER SYSTEM
K933316 · Therex Corp. · Feb 1994
THEREX LOW-PROFILE PORT 1.5MM I.D. X 2.7MM O.D. DETACHED CATHETER SYSTEM
K933350 · Therex Corp. · Feb 1994