Cleared Special

K043140 - EXPRESS AND OASIS CHEST DRAIN

K043140 is an FDA 510(k) clearance for EXPRESS AND OASIS CHEST DRAIN, manufactured by Atrium Medical Corp.. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Special 510(k) pathway after a 23-day FDA review.

K043140 · Atrium Medical Corp. · Anesthesiology device
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Dec 2004
Decision
23d
Days
Class 2
Risk

K043140 is an FDA 510(k) clearance for the EXPRESS AND OASIS CHEST DRAIN. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Atrium Medical Corp. (Hudson, US). The FDA issued a Cleared decision on December 8, 2004 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5830 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Atrium Medical Corp. devices

FDA 510(k) Submission Details - K043140

510(k) Number K043140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2004
Decision Date December 08, 2004
Days to Decision 23 days
Submission Type Special
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
117d faster than avg
Panel avg: 140d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

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 K043140.
AUTOLOG AUTOTRANSFUSION SYSTEM
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HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT)
K053000 · Haemonetics Corp. · Nov 2005
HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM
K043127 · Haemonetics Corp. · Jan 2005
HEMOVAC BLOOD REINFUSION SYSTEM
K041525 · Zimmer, Inc. · Oct 2004
ACCESS CONCENTRATION SYSTEM, MODEL ACC-100, ACCESS DISPOSABLE SET, MODEL ADS-2000
K022348 · Interpore Cross Intl. · Aug 2002
ACCESS SEQUESTRATION SYSTEM
K012406 · Interpore Cross Intl. · Mar 2002