Cleared Traditional

K030936 - RITA CLIPS FOR INFUSION PUMPS

K030936 is an FDA 510(k) clearance for RITA CLIPS FOR INFUSION PUMPS, manufactured by Rita Medical Systems, Inc.. The device is a Class 2 General Hospital device with product code MRZ cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K030936 · Rita Medical Systems, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
7d
Days
Class 2
Risk

K030936 is an FDA 510(k) clearance for the RITA CLIPS FOR INFUSION PUMPS. Classified as Accessories, Pump, Infusion (product code MRZ), Class II - Special Controls.

Submitted by Rita Medical Systems, Inc. (Mountain View, US). The FDA issued a Cleared decision on April 1, 2003 after a review of 7 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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 - K030936

510(k) Number K030936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2003
Decision Date April 01, 2003
Days to Decision 7 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 129d · This submission: 7d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

MRZ Device Classification - Class 2, Special Controls

Product Code MRZ Accessories, Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - MRZ Accessories, Pump, Infusion

All 27
Devices cleared under the same product code (MRZ) and FDA review panel - the closest regulatory comparables to K030936.
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