Cleared Traditional

K912956 - ATRIUM DUAL ATS WATER SEAL CHEST DRAIN UNIT

K912956 is an FDA 510(k) clearance for ATRIUM DUAL ATS WATER SEAL CHEST DRAIN UNIT, 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 144-day FDA review.

K912956 · Atrium Medical Corp. · Anesthesiology device
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Nov 1991
Decision
144d
Days
Class 2
Risk

K912956 is an FDA 510(k) clearance for the ATRIUM DUAL ATS WATER SEAL CHEST DRAIN UNIT. 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 144 days - within the typical 510(k) review window.

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 - K912956

510(k) Number K912956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1991
Decision Date November 29, 1991
Days to Decision 144 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
4d slower than avg
Panel avg: 140d · This submission: 144d
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 K912956.
COBE BRAT SYSTEMS WITHOUT REINFUSION PROTECTION
K913773 · Cobe Cardiovascular, Inc. · Jan 1992
MINI-OP ATS BLOOD RECOVERY BAG, MOEL 2950
K912609 · Atrium Medical Corp. · Nov 1991
MINI-OP ATS BLOOD RECOVERY BAG, MODEL 2955
K912610 · Atrium Medical Corp. · Nov 1991
SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM
K910991 · Shiley, Inc. · Nov 1991
DAVOL POST-OP AUTOTRANSFUSION SYSTEM
K913684 · Davol, Inc. · Nov 1991
ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSION SYSTEM
K912019 · Gish Biomedical, Inc. · Oct 1991