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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Underwriters Laboratories, Inc.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MRZ Accessories, Pump, Infusion

All 47
Devices cleared under the same product code (MRZ) and FDA review panel - the closest regulatory comparables to K030936.
MEDTRONIC MINIMED CARELINK USB CONNECTOR, MODEL NMT 7305
K070438 · Medtronic Minimed, Inc. · Oct 2007
DANA 3CC SYRINGE INSULIN RESERVOIR
K071418 · Sooil Development Co., Ltd. · Sep 2007
HOSPIRA GEMSTAR INFUSION PUMP SYSTEM WITH HOSPIRA GEMSTAR SPRING ASSIST MECHANISM LOCKBOX-7 THERAPY
K051079 · Hospicare, Inc. · May 2005
PREPARE CARTRIDGE
K023890 · Appro Healthcare, Inc. · Feb 2003
MEDTRONIC MINIMED COMLINK, HARDWARE MODEL 7304 & SOFTWARE MODEL 7311
K021974 · Minimed, Inc. · Aug 2002
MEDFUSION 2001 & 2010, MODEL N7215IWC
K012259 · National Custom Ent., Inc. · Sep 2001

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K030936 · RITA CLIPS FOR INFUSION PUMPS
Download PDF FDA Summary Rita Medical Systems,…