Cleared Traditional

MODIFIED SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM (K894668) - FDA 510(k) Clearance

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

K894668 · Shiley, Inc. · Anesthesiology device
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Oct 1989
Decision
87d
Days
Class 2
Risk

K894668 is an FDA 510(k) clearance for the MODIFIED SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on October 20, 1989 after a review of 87 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 K894668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1989
Decision Date October 20, 1989
Days to Decision 87 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
53d faster than avg
Panel avg: 140d · This submission: 87d
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 K894668.
SYSTEM 350
K914053 · Stryker Corp. · Sep 1992
SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM
K910991 · Shiley, Inc. · Nov 1991
VARIDYNE AT POSTOPERATIVE ORTHOPEDIC AUTOTRANSFU.
K900483 · Baxter Healthcare Corp · Aug 1990
DIDECO-SHILEY UNIVERSAL Y
K894294 · Shiley, Inc. · Aug 1989
PHARMASEAL MEDI-VAC STERILE POST-OP AUTOTRANS. SYS
K893578 · Baxter Healthcare Corp · Aug 1989
SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM-PROGRAMM
K884564 · Shiley, Inc. · May 1989