Cleared Traditional

BLOOD RECOVERY/AUTOTRANSFUSION RESERVOIR ATR-2900 (K892443) - FDA 510(k) Clearance

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

K892443 · Gish Biomedical, Inc. · Anesthesiology device
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Nov 1989
Decision
212d
Days
Class 2
Risk

K892443 is an FDA 510(k) clearance for the BLOOD RECOVERY/AUTOTRANSFUSION RESERVOIR ATR-2900. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Gish Biomedical, Inc. (Santa Ana, US). The FDA issued a Cleared decision on November 8, 1989 after a review of 212 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 Gish Biomedical, Inc. devices

Submission Details

510(k) Number K892443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1989
Decision Date November 08, 1989
Days to Decision 212 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 140d · This submission: 212d
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 38
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K892443.
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
MODIFIED SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM
K894668 · Shiley, Inc. · Oct 1989
DIDECO-SHILEY UNIVERSAL Y
K894294 · Shiley, Inc. · Aug 1989
PHARMASEAL MEDI-VAC STERILE POST-OP AUTOTRANS. SYS
K893578 · Baxter Healthcare Corp · Aug 1989