Cleared Traditional

K884564 - SHILEY THERAPEUTIC AUTOTRANSFUSION SYST...

K884564 is an FDA 510(k) clearance for SHILEY THERAPEUTIC AUTOTRANSFUSION SYST..., 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 185-day FDA review.

K884564 · Shiley, Inc. · Anesthesiology device
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May 1989
Decision
185d
Days
Class 2
Risk

K884564 is an FDA 510(k) clearance for the SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM-PROGRAMM. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on May 5, 1989 after a review of 185 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 - K884564

510(k) Number K884564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1988
Decision Date May 05, 1989
Days to Decision 185 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
45d slower than avg
Panel avg: 140d · This submission: 185d
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 K884564.
INLINE AUTOTRANSFUSION SYSTEM
K890171 · Conmedcorp · Jun 1989
HARVESTING TUBE
K892857 · Conmedcorp · Jun 1989
AUTOTRANSFUSION DEVICE
K892819 · Impra, Inc. · May 1989
PLEUR-EVAC(R) A-7002--ADULT/PEDIATRIC DRAINAGE
K884844 · Deknatel, Inc. · Jan 1989
CELL SAVER HAEMOLITE B AUTO. BLOOD RECOVERY SYSTEM
K883934 · Haemonetics Corp. · Dec 1988
PLEUR-EVAC(R)-A-7020-INFANT CHEST DRAIN SYSTEM
K883082 · Deknatel, Inc. · Oct 1988