Cleared Special

K130043 - PLEUR-EVAC SAHARA PLUS CONTINUOUS REINF...

K130043 is an FDA 510(k) clearance for PLEUR-EVAC SAHARA PLUS CONTINUOUS REINF..., manufactured by Teleflexmedical, Inc.. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Special 510(k) pathway after a 35-day FDA review.

K130043 · Teleflexmedical, Inc. · Anesthesiology device
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Feb 2013
Decision
35d
Days
Class 2
Risk

K130043 is an FDA 510(k) clearance for the PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Teleflexmedical, Inc. (Durham, US). The FDA issued a Cleared decision on February 12, 2013 after a review of 35 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Teleflexmedical, Inc. devices

FDA 510(k) Submission Details - K130043

510(k) Number K130043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2013
Decision Date February 12, 2013
Days to Decision 35 days
Submission Type Special
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
105d faster than avg
Panel avg: 140d · This submission: 35d
Pathway characteristics
Modification to existing cleared device.

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
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K130043.
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
XTRA
K131553 · Sorin Group Deutschland GmbH · Mar 2014
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K122262 · Haemonetics Corp. · Oct 2012
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K120586 · Haemonetics Corp. · May 2012
XTRA
K112245 · Sorin Group Italia S.R.L. · Sep 2011