Cleared Traditional

K963098 - PLEUR-EVAC SHARA PLUS MODEL S-2150/CONT...

K963098 is an FDA 510(k) clearance for PLEUR-EVAC SHARA PLUS MODEL S-2150/CONT..., manufactured by Deknatel, Inc.. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K963098 · Deknatel, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
91d
Days
Class 2
Risk

K963098 is an FDA 510(k) clearance for the PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYST.... Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Deknatel, Inc. (Fall River, US). The FDA issued a Cleared decision on November 8, 1996 after a review of 91 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 Deknatel, Inc. devices

FDA 510(k) Submission Details - K963098

510(k) Number K963098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1996
Decision Date November 08, 1996
Days to Decision 91 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
49d faster than avg
Panel avg: 140d · This submission: 91d
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 K963098.
PLEUR-EVAC SAHARA PLUS MODEL S-1150 CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM
K963850 · Deknatel, Inc. · Apr 1997
COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH MODIFIED PLASMA RECOVERY PROGRAM (PRP)
K962689 · Cobe Cardiovascular, Inc. · Jan 1997
DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAG
K964070 · Deknatel, Inc. · Dec 1996
AUTOVAC BP SYSTE, 2000 SERIES
K955010 · Boehringer Laboratories · Jun 1996
CARACELL
K953118 · Medtronic Vascular · Feb 1996
STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII)
K952224 · Stryker Instruments · Nov 1995