Cleared Traditional

K953118 - CARACELL

K953118 is an FDA 510(k) clearance for CARACELL, manufactured by Medtronic Vascular. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Traditional 510(k) pathway after a 235-day FDA review.

K953118 · Medtronic Vascular · Anesthesiology device
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Feb 1996
Decision
235d
Days
Class 2
Risk

K953118 is an FDA 510(k) clearance for the CARACELL. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Medtronic Vascular (Parker, US). The FDA issued a Cleared decision on February 23, 1996 after a review of 235 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 Medtronic Vascular devices

FDA 510(k) Submission Details - K953118

510(k) Number K953118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1995
Decision Date February 23, 1996
Days to Decision 235 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 140d · This submission: 235d
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 K953118.
DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAG
K964070 · Deknatel, Inc. · Dec 1996
PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM(S-100)
K963098 · Deknatel, Inc. · Nov 1996
AUTOVAC BP SYSTE, 2000 SERIES
K955010 · Boehringer Laboratories · Jun 1996
STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII)
K952224 · Stryker Instruments · Nov 1995
BOEHRINGER AUTOVAC(R) 7900 SERIES
K945775 · Boehringer Laboratories · Oct 1995
AUTOFLO INTRA-OP SHED BLOOD AUTORTRANSFUSTION SYS
K944232 · Haemonetics Corp. · Jul 1995