Cleared Traditional

K101806 - AIDERA DIASEND SYSTEM

K101806 is an FDA 510(k) clearance for AIDERA DIASEND SYSTEM, manufactured by Aidera AB. The device is a Class 2 General Hospital device with product code MRZ cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K101806 · Aidera AB · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
162d
Days
Class 2
Risk

K101806 is an FDA 510(k) clearance for the AIDERA DIASEND SYSTEM. Classified as Accessories, Pump, Infusion (product code MRZ), Class II - Special Controls.

Submitted by Aidera AB (Goteborg, SE). The FDA issued a Cleared decision on December 7, 2010 after a review of 162 days - an extended review 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: 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.

FDA 510(k) Submission Details - K101806

510(k) Number K101806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2010
Decision Date December 07, 2010
Days to Decision 162 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
33d slower than avg
Panel avg: 129d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - MRZ Accessories, Pump, Infusion

All 47
Devices cleared under the same product code (MRZ) and FDA review panel - the closest regulatory comparables to K101806.
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K101806 · AIDERA DIASEND SYSTEM
Download PDF FDA Summary Aidera AB