Cleared Traditional

K912704 - ATRIUM 2000 CHEST DRAIN

K912704 is an FDA 510(k) clearance for ATRIUM 2000 CHEST DRAIN, 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 68-day FDA review.

K912704 · Atrium Medical Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1991
Decision
68d
Days
Class 2
Risk

K912704 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 August 26, 1991 after a review of 68 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Atrium Medical Corp. devices

FDA 510(k) Submission Details - K912704

510(k) Number K912704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1991
Decision Date August 26, 1991
Days to Decision 68 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
61d faster than avg
Panel avg: 129d · This submission: 68d
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 K912704.
ATRIUM DRY SUCTION CONTROL WATER SEAL CHEST DRAIN
K950677 · Atrium Medical Corp. · Apr 1995
PM9000 VAC TRAP
K941818 · Precision Medical, Inc. · Dec 1994
THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM
K932327 · Davol, Inc. · Jul 1993
PLEUR-EVAC CHEST DRAINAGE SYSTEMS
K905768 · Deknatel, Inc. · Feb 1991
ATRIUM 2000, CHEST DRAIN
K897125 · Atrium Medical Corp. · Mar 1990
PLEUR-EVAC(R) A-6020--INFANT SINGLE USE CHEST DRAI
K896697 · Deknatel, Inc. · Feb 1990