Cleared Traditional

K093535 - AUTOLOG AUTOTRANSFUSION SYSTEM

K093535 is an FDA 510(k) clearance for AUTOLOG AUTOTRANSFUSION SYSTEM, manufactured by Medtronic, Inc.. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K093535 · Medtronic, Inc. · Anesthesiology device
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Mar 2010
Decision
126d
Days
Class 2
Risk

K093535 is an FDA 510(k) clearance for the AUTOLOG AUTOTRANSFUSION SYSTEM. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Medtronic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on March 22, 2010 after a review of 126 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic, Inc. devices

FDA 510(k) Submission Details - K093535

510(k) Number K093535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2009
Decision Date March 22, 2010
Days to Decision 126 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
14d faster than avg
Panel avg: 140d · This submission: 126d
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 137
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K093535.
HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM
K101907 · Haemonetics Corp. · Dec 2010
PREASSEMBLED SURGICAL WASH SET
K103202 · Sorin Group Italia S.R.L. · Nov 2010
XTRA AUTOTRANSFUSION SYSTEM
K101586 · Sorin Group Italia S.R.L. · Oct 2010
HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT)
K053000 · Haemonetics Corp. · Nov 2005
HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM
K043127 · Haemonetics Corp. · Jan 2005
EXPRESS AND OASIS CHEST DRAIN
K043140 · Atrium Medical Corp. · Dec 2004