Cleared Traditional

K083221 - AIDERA DIASEND

K083221 is an FDA 510(k) clearance for AIDERA DIASEND, 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 95-day FDA review.

K083221 · Aidera AB · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
95d
Days
Class 2
Risk

K083221 is an FDA 510(k) clearance for the AIDERA DIASEND. 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 February 3, 2009 after a review of 95 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 Aidera AB devices

FDA 510(k) Submission Details - K083221

510(k) Number K083221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2008
Decision Date February 03, 2009
Days to Decision 95 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
34d faster than avg
Panel avg: 129d · This submission: 95d
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 22
Devices cleared under the same product code (MRZ) and FDA review panel - the closest regulatory comparables to K083221.
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K072955 · Smiths Medical MD, Inc. · Feb 2008