Cleared Traditional

K912609 - MINI-OP ATS BLOOD RECOVERY BAG

K912609 is an FDA 510(k) clearance for MINI-OP ATS BLOOD RECOVERY BAG, manufactured by Atrium Medical Corp.. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K912609 · Atrium Medical Corp. · Anesthesiology device
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Nov 1991
Decision
170d
Days
Class 2
Risk

K912609 is an FDA 510(k) clearance for the MINI-OP ATS BLOOD RECOVERY BAG, MOEL 2950. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Atrium Medical Corp. (Hollis, US). The FDA issued a Cleared decision on November 29, 1991 after a review of 170 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 Atrium Medical Corp. devices

FDA 510(k) Submission Details - K912609

510(k) Number K912609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1991
Decision Date November 29, 1991
Days to Decision 170 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 140d · This submission: 170d
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 K912609.
DAVOL ORTHOPAEDIC AUTOTRANSFUSION SYSTEM
K914119 · Davol, Inc. · Dec 1992
SYSTEM 350
K914053 · Stryker Corp. · Sep 1992
COBE BRAT SYSTEMS WITHOUT REINFUSION PROTECTION
K913773 · Cobe Cardiovascular, Inc. · Jan 1992
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
SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM
K910991 · Shiley, Inc. · Nov 1991