Cleared Traditional

K110782 - XVAC

K110782 is an FDA 510(k) clearance for XVAC, manufactured by Sorin Group Italia S.R.L.. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K110782 · Sorin Group Italia S.R.L. · Anesthesiology device
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Apr 2011
Decision
17d
Days
Class 2
Risk

K110782 is an FDA 510(k) clearance for the XVAC. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Sorin Group Italia S.R.L. (Waltham, US). The FDA issued a Cleared decision on April 7, 2011 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5830 - the FDA anesthesiology and respiratory 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.

View all Sorin Group Italia S.R.L. devices

FDA 510(k) Submission Details - K110782

510(k) Number K110782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2011
Decision Date April 07, 2011
Days to Decision 17 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
123d faster than avg
Panel avg: 140d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAC Device Classification - Class 2, Special Controls

Product Code CAC Apparatus, Autotransfusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5830
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - CAC Apparatus, Autotransfusion

All 145
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