Cleared Traditional

GO MEDICAL BALLOON INFUSION SYSTEM (K000263) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K000263 · Go Medical Industries Pty. , Ltd. · General Hospital
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May 2000
Decision
102d
Days
Class 2
Risk

K000263 is an FDA 510(k) clearance for the GO MEDICAL BALLOON INFUSION SYSTEM. Classified as Pump, Infusion, Elastomeric (product code MEB), Class II - Special Controls.

Submitted by Go Medical Industries Pty. , Ltd. (Subiaco, Perth, AU). The FDA issued a Cleared decision on May 9, 2000 after a review of 102 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Go Medical Industries Pty. , Ltd. devices

Submission Details

510(k) Number K000263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2000
Decision Date May 09, 2000
Days to Decision 102 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 129d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MEB Pump, Infusion, Elastomeric
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 - MEB Pump, Infusion, Elastomeric

All 87
Devices cleared under the same product code (MEB) and FDA review panel - the closest regulatory comparables to K000263.
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SEMPERFLO INFUSION SYSTEM
K052999 · Ethicon, Inc. · Mar 2006