Cleared Traditional

K955010 - AUTOVAC BP SYSTE, 2000 SERIES

K955010 is an FDA 510(k) clearance for AUTOVAC BP SYSTE, manufactured by Boehringer Laboratories. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K955010 · Boehringer Laboratories · Anesthesiology device
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Jun 1996
Decision
232d
Days
Class 2
Risk

K955010 is an FDA 510(k) clearance for the AUTOVAC BP SYSTE, 2000 SERIES. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Boehringer Laboratories (Norristown, US). The FDA issued a Cleared decision on June 20, 1996 after a review of 232 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 Boehringer Laboratories devices

FDA 510(k) Submission Details - K955010

510(k) Number K955010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1995
Decision Date June 20, 1996
Days to Decision 232 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
92d slower than avg
Panel avg: 140d · This submission: 232d
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 165
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K955010.
HAEMOCELL SYSTEM 350 OR S350
K960734 · Haemocell Plc · Dec 1996
PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM(S-100)
K963098 · Deknatel, Inc. · Nov 1996
C.A.T.S. CONTINUOUS AUTOTRANSFUSION SYSTEM
K960006 · Fresenius AG · Jul 1996
LEVEL 1 BLOOD STREAM RECOVERY SYSTEM
K942844 · Level 1 Technologies, Inc. · Apr 1996
BETATRANS I AND II
K951592 · Duxbury Scientific, Inc. · Mar 1996
CARACELL
K953118 · Medtronic Vascular · Feb 1996