Cleared Traditional

SURESET INFUSION SET, MODEL 8023 (K012429) - FDA 510(k) Clearance

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

K012429 · Applied Diabetes Research, Incorporated · General Hospital
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Nov 2001
Decision
98d
Days
Class 2
Risk

K012429 is an FDA 510(k) clearance for the SURESET INFUSION SET, MODEL 8023. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Applied Diabetes Research, Incorporated (Chapel Hill, US). The FDA issued a Cleared decision on November 6, 2001 after a review of 98 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 Applied Diabetes Research, Incorporated devices

Submission Details

510(k) Number K012429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2001
Decision Date November 06, 2001
Days to Decision 98 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
31d faster than avg
Panel avg: 129d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 208
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K002006 · Abbott Laboratories · Aug 2000
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K991985 · Cook, Inc. · Aug 1999