Cleared Traditional

K952537 - THEREX LOW PROFILE TITANIUM MODEL 1.0MM...

K952537 is an FDA 510(k) clearance for THEREX LOW PROFILE TITANIUM MODEL 1.0MM..., 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 36-day FDA review.

K952537 · Therex Corp. · General Hospital
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Jul 1995
Decision
36d
Days
Class 2
Risk

K952537 is an FDA 510(k) clearance for the THEREX LOW PROFILE TITANIUM MODEL 1.0MM I.D./1.8MM O.D.. 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 July 6, 1995 after a review of 36 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 - K952537

510(k) Number K952537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1995
Decision Date July 06, 1995
Days to Decision 36 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
93d faster than avg
Panel avg: 129d · This submission: 36d
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
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