Cleared Traditional

K955010 - AUTOVAC BP SYSTE, 2000 SERIES (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 139d · This submission: 232d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 194
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