Cleared Traditional

K984496 - ATRIUM MEDICAL CORPORATION EXPRESS CHES...

K984496 is an FDA 510(k) clearance for ATRIUM MEDICAL CORPORATION EXPRESS CHES..., manufactured by Atrium Medical Corp.. The device is a Class 2 General Hospital device with product code KDQ cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K984496 · Atrium Medical Corp. · General Hospital
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May 1999
Decision
139d
Days
Class 2
Risk

K984496 is an FDA 510(k) clearance for the ATRIUM MEDICAL CORPORATION EXPRESS 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 May 5, 1999 after a review of 139 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Atrium Medical Corp. devices

FDA 510(k) Submission Details - K984496

510(k) Number K984496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1998
Decision Date May 05, 1999
Days to Decision 139 days
Submission Type Traditional
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
10d slower than avg
Panel avg: 129d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K984496.
EXPRESS CHEST DRAIN
K081718 · Atrium Medical Corp. · Jul 2008
OCEAN CHEST DRAIN
K043582 · Atrium Medical Corp. · Jan 2005
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