Cleared Abbreviated

K132011 - APOTECA DUG COMPOUNDING DOSING DEVICE,APOTECA I.V. TRANSFER SET (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K132011 · Aea Srl · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2014
Decision
263d
Days
Class 2
Risk

K132011 is an FDA 510(k) clearance for the APOTECA DUG COMPOUNDING DOSING DEVICE,APOTECA I.V. TRANSFER SET. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Aea Srl (Angeli Di Rosora, IT). The FDA issued a Cleared decision on March 21, 2014 after a review of 263 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Aea Srl devices

Submission Details

510(k) Number K132011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2013
Decision Date March 21, 2014
Days to Decision 263 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 128d · This submission: 263d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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.

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All 748
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