Cleared Traditional

K062579 - OMNIPICC P.I.

K062579 is an FDA 510(k) clearance for OMNIPICC P.I., manufactured by Rita Medical Systems, Inc.. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K062579 · Rita Medical Systems, Inc. · General Hospital
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Nov 2006
Decision
89d
Days
Class 2
Risk

K062579 is an FDA 510(k) clearance for the OMNIPICC P.I.. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Rita Medical Systems, Inc. (Manchester, US). The FDA issued a Cleared decision on November 28, 2006 after a review of 89 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - 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 Rita Medical Systems, Inc. devices

FDA 510(k) Submission Details - K062579

510(k) Number K062579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2006
Decision Date November 28, 2006
Days to Decision 89 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
40d faster than avg
Panel avg: 129d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJS Device Classification - Class 2, Special Controls

Product Code LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5970
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 - LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

All 230
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