Cleared Traditional

K897125 - ATRIUM 2000

K897125 is an FDA 510(k) clearance for ATRIUM 2000, 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 94-day FDA review.

K897125 · Atrium Medical Corp. · General Hospital
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Mar 1990
Decision
94d
Days
Class 2
Risk

K897125 is an FDA 510(k) clearance for the ATRIUM 2000, CHEST DRAIN. Classified as Bottle, Collection, Vacuum (product code KDQ), Class II - Special Controls.

Submitted by Atrium Medical Corp. (Hollis, US). The FDA issued a Cleared decision on March 30, 1990 after a review of 94 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 - K897125

510(k) Number K897125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1989
Decision Date March 30, 1990
Days to Decision 94 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 129d · This submission: 94d
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 K897125.
THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM
K932327 · Davol, Inc. · Jul 1993
ATRIUM 2000 CHEST DRAIN
K912704 · Atrium Medical Corp. · Aug 1991
PLEUR-EVAC CHEST DRAINAGE SYSTEMS
K905768 · Deknatel, Inc. · Feb 1991
PLEUR-EVAC(R) A-6020--INFANT SINGLE USE CHEST DRAI
K896697 · Deknatel, Inc. · Feb 1990
THORA-KLEX CHEST DRAINAGE UNIT
K896127 · Davol, Inc. · Jan 1990
PLEUR-EVAC A-8002--ADULT/PEDIATRIC DUAL COLLECTION
K892915 · Deknatel, Inc. · Jun 1989