Cleared Traditional

K945775 - BOEHRINGER AUTOVAC(R) 7900 SERIES

K945775 is an FDA 510(k) clearance for BOEHRINGER AUTOVAC 7900 SERIES, 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 328-day FDA review.

K945775 · Boehringer Laboratories · Anesthesiology device
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Oct 1995
Decision
328d
Days
Class 2
Risk

K945775 is an FDA 510(k) clearance for the BOEHRINGER AUTOVAC(R) 7900 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 October 19, 1995 after a review of 328 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K945775

510(k) Number K945775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1994
Decision Date October 19, 1995
Days to Decision 328 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
188d slower than avg
Panel avg: 140d · This submission: 328d
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 K945775.
BETATRANS I AND II
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AUTOFLO INTRA-OP SHED BLOOD AUTORTRANSFUSTION SYS
K944232 · Haemonetics Corp. · Jul 1995
ARGYLE AQUA-SEAL CONTINUOUS AUTOTRANSFUSION CHEST DRAINAGE UNIT
K942791 · Sherwood Medical Co. · May 1995
DAVOL ATS
K931899 · Davol, Inc. · Nov 1994