Cleared Traditional

K910991 - SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM

K910991 is an FDA 510(k) clearance for SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM, manufactured by Shiley, Inc.. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K910991 · Shiley, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K910991

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.

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 137
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K910991.
MINI-OP ATS BLOOD RECOVERY BAG, MOEL 2950
K912609 · Atrium Medical Corp. · Nov 1991
MINI-OP ATS BLOOD RECOVERY BAG, MODEL 2955
K912610 · Atrium Medical Corp. · Nov 1991
ATRIUM DUAL ATS WATER SEAL CHEST DRAIN UNIT
K912956 · Atrium Medical Corp. · Nov 1991
DAVOL POST-OP AUTOTRANSFUSION SYSTEM
K913684 · Davol, Inc. · Nov 1991
ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSION SYSTEM
K912019 · Gish Biomedical, Inc. · Oct 1991
AUTOVAC (R) AUTOTRANSFUSION SYSTEM, 7900 MODIFIED
K904164 · Boehringer Laboratories · Sep 1991