Cleared Traditional

K162423 - Haemonetics Cell Saver Elite/Elite+ Aut...

K162423 is an FDA 510(k) clearance for Haemonetics Cell Saver Elite/Elite+ Aut..., manufactured by Haemonetics Corporation. 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.

K162423 · Haemonetics Corporation · Anesthesiology device
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Jan 2017
Decision
126d
Days
Class 2
Risk

K162423 is an FDA 510(k) clearance for the Haemonetics Cell Saver Elite/Elite+ Autotransfusion System. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Haemonetics Corporation (Braintree, US). The FDA issued a Cleared decision on January 3, 2017 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 Haemonetics Corporation devices

FDA 510(k) Submission Details - K162423

510(k) Number K162423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2016
Decision Date January 03, 2017
Days to Decision 126 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
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 139
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K162423.
CATSmart
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CATSmart
K180831 · Fresenius Kabi AG · Dec 2018
autoLog IQ Autotransfusion System
K181954 · Medtronic Perfusion Systems · Aug 2018
PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM
K140205 · Teleflexmedical, Inc. · Oct 2014
PLEUR-EVAC PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM
K140197 · Teleflexmedical, Inc. · Oct 2014
PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM
K130043 · Teleflexmedical, Inc. · Feb 2013