Cleared Traditional

SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM (K910991) - FDA 510(k) Clearance

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

K910991 · Shiley, Inc. · Anesthesiology device
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Nov 1991
Decision
265d
Days
Class 2
Risk

K910991 is an FDA 510(k) clearance for the 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 November 27, 1991 after a review of 265 days - an extended review 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: 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 Shiley, Inc. devices

Submission Details

510(k) Number K910991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1991
Decision Date November 27, 1991
Days to Decision 265 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
125d slower than avg
Panel avg: 140d · This submission: 265d
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 K910991.
ARGYLE AQUA-SEAL CONTINUOUS AUTOTRANSFUSION CHEST DRAINAGE UNIT
K942791 · Sherwood Medical Co. · May 1995
AUTOTRANSFUSION SUCTION RESERVOIR WITH FILTER
K940678 · Baxter Healthcare Corp · Apr 1994
SYSTEM 350
K914053 · Stryker Corp. · Sep 1992
VARIDYNE AT POSTOPERATIVE ORTHOPEDIC AUTOTRANSFU.
K900483 · Baxter Healthcare Corp · Aug 1990
MODIFIED SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM
K894668 · Shiley, Inc. · Oct 1989
DIDECO-SHILEY UNIVERSAL Y
K894294 · Shiley, Inc. · Aug 1989