Cleared Traditional

K942412 - THEREX LOW-PROFILE PORT - TITANIUM MODEL

K942412 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 91-day FDA review.

K942412 · Therex Corp. · General Hospital
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Aug 1994
Decision
91d
Days
Class 2
Risk

K942412 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 August 19, 1994 after a review of 91 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 - K942412

510(k) Number K942412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1994
Decision Date August 19, 1994
Days to Decision 91 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
38d faster than avg
Panel avg: 129d · This submission: 91d
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 K942412.
STRATO MEDICAL INFUSE-A-PORT/INFUSE-A-KIT PERIPORT PERIPHERAL ACCESS SYSTEM
K934518 · Strato Medical Corp. · Jan 1995
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K932411 · Med Institute, Inc. · Sep 1994
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K934167 · Pudenz-Schulte Medical Research Corp. · Jul 1994
IPI LOW PROFILE IMPORT
K934796 · Pudenz-Schulte Medical Research Corp. · Jul 1994