Cleared Traditional

K024056 - SURESET 3.0 ML RESERVOIR, MODEL 24-103

K024056 is an FDA 510(k) clearance for SURESET 3.0 ML RESERVOIR, manufactured by Applied Diabetes Research, Incorporated. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K024056 · Applied Diabetes Research, Incorporated · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
39d
Days
Class 2
Risk

K024056 is an FDA 510(k) clearance for the SURESET 3.0 ML RESERVOIR, MODEL 24-103. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Applied Diabetes Research, Incorporated (Laguna Niguel, US). The FDA issued a Cleared decision on January 17, 2003 after a review of 39 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 - K024056

510(k) Number K024056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2002
Decision Date January 17, 2003
Days to Decision 39 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 129d · This submission: 39d
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 842
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K024056.
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K023264 · Alaris Medical Systems, Inc. · Dec 2002
AUTOMED 3300 AND 3400 INFUSION PUMP SYSTEM
K023491 · Help Technologies · Dec 2002
K024056 · SURESET 3.0 ML RESERVOIR, MODEL 24-103
Download PDF FDA Summary Applied Diabetes Rese…