Cleared Traditional

K120953 - PLEUR-EVAC SAHARA PLUS CONTINOUS REINFU...

K120953 is an FDA 510(k) clearance for PLEUR-EVAC SAHARA PLUS CONTINOUS REINFU..., manufactured by Tlelflex Medical, Inc.. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K120953 · Tlelflex Medical, Inc. · Anesthesiology device
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Dec 2012
Decision
255d
Days
Class 2
Risk

K120953 is an FDA 510(k) clearance for the PLEUR-EVAC SAHARA PLUS CONTINOUS REINFUSION AUTOTRANSFUSION SYSTEM. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Tlelflex Medical, Inc. (Durham, US). The FDA issued a Cleared decision on December 10, 2012 after a review of 255 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 Tlelflex Medical, Inc. devices

FDA 510(k) Submission Details - K120953

510(k) Number K120953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2012
Decision Date December 10, 2012
Days to Decision 255 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
115d slower than avg
Panel avg: 140d · This submission: 255d
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 146
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K120953.
PLEUR-EVAC PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM
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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
CELL SAVER ELITE
K120586 · Haemonetics Corp. · May 2012
XTRA
K112245 · Sorin Group Italia S.R.L. · Sep 2011