Cleared Traditional

DIDECO-SHILEY AUTOTRANS BT 795/AA (K881683) - FDA 510(k) Clearance

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

K881683 · Shiley, Inc. · Anesthesiology device
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Jun 1988
Decision
69d
Days
Class 2
Risk

K881683 is an FDA 510(k) clearance for the DIDECO-SHILEY AUTOTRANS BT 795/AA. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on June 27, 1988 after a review of 69 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 Shiley, Inc. devices

Submission Details

510(k) Number K881683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1988
Decision Date June 27, 1988
Days to Decision 69 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
71d faster than avg
Panel avg: 140d · This submission: 69d
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 37
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K881683.
CBC/CONSTAVAC BLOOD CONSERVATION SYSTEM
K881350 · Stryker Corp. · Sep 1988
ARGYLE AUTOTRANSFUSION BAG
K882757 · Sherwood Medical Co. · Sep 1988
DIDECO-SHILEY FLUID COLLECTION BAG
K881692 · Shiley, Inc. · Jul 1988
DIDECO-SHILEY FEED TUBE SUPPORT ARMS AND HOOK
K881421 · Shiley, Inc. · May 1988
DAVOL INTRAOPERATIVE AUTOTRANSFUSION KIT
K872927 · C.R. Bard, Inc. · Oct 1987
SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM (REMOTE)
K872814 · Shiley, Inc. · Aug 1987