Cleared Traditional

K030323 - MRI-CADDY

K030323 is an FDA 510(k) clearance for MRI-CADDY, manufactured by Mammendorfer Institute For Physics & Medicine GmbH. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K030323 · Mammendorfer Institute For Physics & Medicine GmbH · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
62d
Days
Class 2
Risk

K030323 is an FDA 510(k) clearance for the MRI-CADDY. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Mammendorfer Institute For Physics & Medicine GmbH (Golden, US). The FDA issued a Cleared decision on April 2, 2003 after a review of 62 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 Mammendorfer Institute For Physics & Medicine GmbH devices

FDA 510(k) Submission Details - K030323

510(k) Number K030323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2003
Decision Date April 02, 2003
Days to Decision 62 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
67d faster than avg
Panel avg: 129d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

Product Code FRN 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 - FRN Pump, Infusion

All 481
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K030323.
ANSPACH IRRIGATION PUMP AND IRRIGATION PUMP II
K030576 · The Anspach Effort, Inc. · May 2003
ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULE
K031185 · Abbott Laboratories · Apr 2003
MODIFICATION TO STRYKER PAINPUMP2
K030885 · Stryker Instruments · Apr 2003
VISTA BASIC WITH FM SYSTEM
K023189 · B.Braun Medical, Inc. · Mar 2003
SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800
K023083 · Mettler Electronics Corp. · Feb 2003
ABBOTT PLUM A+ INFUSION PUMP, MODEL 12391
K024084 · Abbott Laboratories · Dec 2002