Cleared Special

K043582 - OCEAN CHEST DRAIN

K043582 is an FDA 510(k) clearance for OCEAN CHEST DRAIN, manufactured by Atrium Medical Corp.. The device is a Class 2 General Hospital device with product code KDQ cleared through the Special 510(k) pathway after a 24-day FDA review.

K043582 · Atrium Medical Corp. · General Hospital
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Jan 2005
Decision
24d
Days
Class 2
Risk

K043582 is an FDA 510(k) clearance for the OCEAN CHEST DRAIN. Classified as Bottle, Collection, Vacuum (product code KDQ), Class II - Special Controls.

Submitted by Atrium Medical Corp. (Hudson, US). The FDA issued a Cleared decision on January 21, 2005 after a review of 24 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - the FDA general hospital 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 - K043582

510(k) Number K043582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2004
Decision Date January 21, 2005
Days to Decision 24 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 129d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

KDQ Device Classification - Class 2, Special Controls

Product Code KDQ Bottle, Collection, Vacuum
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
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 General Hospital devices follow this clearance model.

Regulatory Peers - KDQ Bottle, Collection, Vacuum

All 34
Devices cleared under the same product code (KDQ) and FDA review panel - the closest regulatory comparables to K043582.
EXPRESS CHEST DRAIN
K081718 · Atrium Medical Corp. · Jul 2008
ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN
K984496 · Atrium Medical Corp. · May 1999
PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR
K962856 · Deknatel, Inc. · Aug 1996
MUCUS SPECIMEN TRAP
K962168 · Sage Products, Inc. · Jul 1996
ATRIUM DRY SUCTION CONTROL WATER SEAL CHEST DRAIN
K950677 · Atrium Medical Corp. · Apr 1995
PM9000 VAC TRAP
K941818 · Precision Medical, Inc. · Dec 1994