Cleared Traditional

K140197 - PLEUR-EVAC PLUS CONTINUOUS REINFUSION A...

K140197 is an FDA 510(k) clearance for PLEUR-EVAC PLUS CONTINUOUS REINFUSION A..., manufactured by Teleflexmedical, Inc.. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K140197 · Teleflexmedical, Inc. · Anesthesiology device
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Oct 2014
Decision
267d
Days
Class 2
Risk

K140197 is an FDA 510(k) clearance for the PLEUR-EVAC PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Teleflexmedical, Inc. (Research Triangle Park, US). The FDA issued a Cleared decision on October 21, 2014 after a review of 267 days - an extended review 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: 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 Teleflexmedical, Inc. devices

FDA 510(k) Submission Details - K140197

510(k) Number K140197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2014
Decision Date October 21, 2014
Days to Decision 267 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
127d slower than avg
Panel avg: 140d · This submission: 267d
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
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K140197.
CATSmart
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K181954 · Medtronic Perfusion Systems · Aug 2018
PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM
K140205 · Teleflexmedical, Inc. · Oct 2014
XTRA
K131553 · Sorin Group Deutschland GmbH · Mar 2014
PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM
K130043 · Teleflexmedical, Inc. · Feb 2013
ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEM
K122262 · Haemonetics Corp. · Oct 2012