Cleared Traditional

K950677 - ATRIUM DRY SUCTION CONTROL WATER SEAL C...

K950677 is an FDA 510(k) clearance for ATRIUM DRY SUCTION CONTROL WATER SEAL C..., 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 58-day FDA review.

K950677 · Atrium Medical Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
58d
Days
Class 2
Risk

K950677 is an FDA 510(k) clearance for the ATRIUM DRY SUCTION CONTROL WATER SEAL 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 April 13, 1995 after a review of 58 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 - K950677

510(k) Number K950677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1995
Decision Date April 13, 1995
Days to Decision 58 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 129d · This submission: 58d
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 K950677.
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
PM9000 VAC TRAP
K941818 · Precision Medical, Inc. · Dec 1994
THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM
K932327 · Davol, Inc. · Jul 1993
ATRIUM 2000 CHEST DRAIN
K912704 · Atrium Medical Corp. · Aug 1991