Cleared Traditional

K862684 - AUTO-VAC (TM) AUTOTRANSFUSION RESERV, MODEL 7900

K862684 is an FDA 510(k) clearance for AUTO-VAC (TM) AUTOTRANSFUSION RESERV, 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 94-day FDA review.

K862684 · Boehringer Laboratories · Anesthesiology device
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Oct 1986
Decision
94d
Days
Class 2
Risk

K862684 is an FDA 510(k) clearance for the AUTO-VAC (TM) AUTOTRANSFUSION RESERV, MODEL 7900. 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 17, 1986 after a review of 94 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 - K862684

510(k) Number K862684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1986
Decision Date October 17, 1986
Days to Decision 94 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
46d faster than avg
Panel avg: 140d · This submission: 94d
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 K862684.
THORA-DRAIN(R) ABT SYSTEM
K871624 · Sherwood Medical Co. · Jun 1987
BT-795/ATS
K871847 · Electromedics, Inc. · Jun 1987
ARGYLE SENTINEL SEAL AUTOTRANSFUSION SYSTEM
K864374 · Sherwood Medical Co. · Mar 1987
PHARMASEAL MEDI-VAC INTRA-OPER. AUTOTRANSFUS. KIT
K861677 · American Pharmaseal Div. Ahsc · Jun 1986
BT-795/P AUTOMATED AUTOTRANS
K860306 · Electromedics, Inc. · Mar 1986
EXU-BAG CSU-1200(DISPOS)CANISTER 602-2(NON-DISPOS
K852178 · American Omni Medical, Inc. · Dec 1985