Cleared Traditional

K892443 - BLOOD RECOVERY/AUTOTRANSFUSION RESERVOI...

K892443 is an FDA 510(k) clearance for BLOOD RECOVERY/AUTOTRANSFUSION RESERVOI..., manufactured by Gish Biomedical, Inc.. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Traditional 510(k) pathway after a 212-day FDA review.

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

FDA 510(k) Submission Details - K892443

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
Combination Product No
PCCP Authorized No
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.

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 K892443.
AUTOTRANSFUSION RESERVIOR MODEL 7900 MODIFICATION
K895297 · Boehringer Laboratories · Mar 1990
ATRIUM 2050 CHEST DRAIN BLOOD RECOVERY SYSTEM
K897126 · Atrium Medical Corp. · Mar 1990
ATRIUM 2052 CHEST DRAIN, DUAL COLLECTION BLOOD
K897127 · Atrium Medical Corp. · Mar 1990
MODIFIED SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM
K894668 · Shiley, Inc. · Oct 1989
ORTHOPEDIC WOUND DRAINAGE SET WITH TROCAR
K893394 · Haemonetics Corp. · Oct 1989
DIDECO-SHILEY UNIVERSAL Y
K894294 · Shiley, Inc. · Aug 1989