Cleared Traditional

K895297 - AUTOTRANSFUSION RESERVIOR MODEL 7900 MO...

K895297 is the FDA 510(k) clearance for AUTOTRANSFUSION RESERVIOR MODEL 7900 MO... by Boehringer Laboratories. It is a Class 2 Anesthesiology device (product code CAC) cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K895297 · Boehringer Laboratories · Anesthesiology device
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Mar 1990
Decision
200d
Days
Class 2
Risk

K895297 is an FDA 510(k) clearance for the AUTOTRANSFUSION RESERVIOR MODEL 7900 MODIFICATION. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Boehringer Laboratories (Norristown, US). The FDA issued a Cleared decision on March 13, 1990 after a review of 200 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 Boehringer Laboratories devices

Submission Details

510(k) Number K895297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1989
Decision Date March 13, 1990
Days to Decision 200 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 140d · This submission: 200d
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 47
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K895297.
VARIDYNE AT POSTOPERATIVE ORTHOPEDIC AUTOTRANSFU.
K900483 · Baxter Healthcare Corp · Aug 1990
COBE CLOSED WOUND DRAINAGE KIT
K902759 · Cobe Laboratories, Inc. · Jul 1990
COBE AUTOLOGOUS BLOOD SALVAGE RESERV W/W/O FILTER
K902671 · Cobe Laboratories, Inc. · Jul 1990
BLOOD RECOVERY/AUTOTRANSFUSION RESERVOIR ATR-2900
K892443 · Gish Biomedical, Inc. · Nov 1989
MODIFIED SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM
K894668 · Shiley, Inc. · Oct 1989
DIDECO-SHILEY UNIVERSAL Y
K894294 · Shiley, Inc. · Aug 1989