Cleared Traditional

DIDECO-SHILEY WASTE COLLECTION BAG (K872158) - FDA 510(k) Clearance

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

K872158 · Shiley, Inc. · Anesthesiology device
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Jul 1987
Decision
47d
Days
Class 2
Risk

K872158 is an FDA 510(k) clearance for the DIDECO-SHILEY WASTE COLLECTION BAG. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on July 21, 1987 after a review of 47 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 K872158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1987
Decision Date July 21, 1987
Days to Decision 47 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
93d faster than avg
Panel avg: 140d · This submission: 47d
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 K872158.
DAVOL INTRAOPERATIVE AUTOTRANSFUSION KIT
K872927 · C.R. Bard, Inc. · Oct 1987
SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM (REMOTE)
K872814 · Shiley, Inc. · Aug 1987
DIDECO-SHILEY BLOOD SEPARATION WASH BOWL
K872160 · Shiley, Inc. · Jul 1987
DIDECO-SHILEY BLOOD REINFUSION BAG
K872162 · Shiley, Inc. · Jul 1987
THORA-DRAIN(R) ABT SYSTEM
K871624 · Sherwood Medical Co. · Jun 1987
ARGYLE SENTINEL SEAL AUTOTRANSFUSION SYSTEM
K864374 · Sherwood Medical Co. · Mar 1987