Cleared Traditional

K122834 - POLYSITE IMPLANTABLE INFUSION PORTS

K122834 is an FDA 510(k) clearance for POLYSITE IMPLANTABLE INFUSION PORTS, manufactured by Perouse Medical. The device is a Class 2 General Hospital device with product code LJT cleared through the Traditional 510(k) pathway after a 450-day FDA review.

K122834 · Perouse Medical · General Hospital
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Dec 2013
Decision
450d
Days
Class 2
Risk

K122834 is an FDA 510(k) clearance for the POLYSITE IMPLANTABLE INFUSION PORTS. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Perouse Medical (France, FR). The FDA issued a Cleared decision on December 11, 2013 after a review of 450 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Perouse Medical devices

FDA 510(k) Submission Details - K122834

510(k) Number K122834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2012
Decision Date December 11, 2013
Days to Decision 450 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
321d slower than avg
Panel avg: 129d · This submission: 450d
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 198
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K122834.
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