Cleared Traditional

K881129 - AUTO-VAC INTRAOPERATIVE AUTOTRANS. RESERVOIR #7904

K881129 is an FDA 510(k) clearance for AUTO-VAC INTRAOPERATIVE AUTOTRANS. RESE..., 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 90-day FDA review.

K881129 · Boehringer Laboratories · Anesthesiology device
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Jun 1988
Decision
90d
Days
Class 2
Risk

K881129 is an FDA 510(k) clearance for the AUTO-VAC INTRAOPERATIVE AUTOTRANS. RESERVOIR #7904. 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 14, 1988 after a review of 90 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 Boehringer Laboratories devices

FDA 510(k) Submission Details - K881129

510(k) Number K881129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1988
Decision Date June 14, 1988
Days to Decision 90 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 140d · This submission: 90d
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 147
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K881129.
ARGYLE AUTOTRANSFUSION BAG
K882757 · Sherwood Medical Co. · Sep 1988
DIDECO-SHILEY FLUID COLLECTION BAG
K881692 · Shiley, Inc. · Jul 1988
DIDECO-SHILEY AUTOTRANS BT 795/AA
K881683 · Shiley, Inc. · Jun 1988
DIDECO-SHILEY FEED TUBE SUPPORT ARMS AND HOOK
K881421 · Shiley, Inc. · May 1988
PLEUR-EVAC--A-5002 CHEST DRAINAGE SYSTEM W/AUTO
K880162 · Deknatel, Inc. · Mar 1988
AUTOTRANSFUSION APPARATUS
K873807 · Biodynamics Corp. · Mar 1988