Cleared Traditional

K872927 - DAVOL INTRAOPERATIVE AUTOTRANSFUSION KIT

K872927 is an FDA 510(k) clearance for DAVOL INTRAOPERATIVE AUTOTRANSFUSION KIT, manufactured by C.R. Bard, Inc.. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K872927 · C.R. Bard, Inc. · Anesthesiology device
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Oct 1987
Decision
74d
Days
Class 2
Risk

K872927 is an FDA 510(k) clearance for the DAVOL INTRAOPERATIVE AUTOTRANSFUSION KIT. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Murray Hill, US). The FDA issued a Cleared decision on October 9, 1987 after a review of 74 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K872927

510(k) Number K872927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1987
Decision Date October 09, 1987
Days to Decision 74 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
66d faster than avg
Panel avg: 140d · This submission: 74d
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 145
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K872927.
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
SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM (REMOTE)
K872814 · Shiley, Inc. · Aug 1987
DIDECO-SHILEY BLOOD SEPARATION WASH BOWL
K872160 · Shiley, Inc. · Jul 1987
DIDECO-SHILEY WASTE COLLECTION BAG
K872158 · Shiley, Inc. · Jul 1987