Cleared Traditional

ATRIUM DRY SUCTION CONTROL WATER SEAL CHEST DRAIN (K950677) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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 9
Devices cleared under the same product code (KDQ) and FDA review panel - the closest regulatory comparables to K950677.
BARD PARKER THORACIC VENT
K854634 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1985
GRECO-HARVEY SURFACTANT BONDED CATH FOR ANESTHESIO
K851244 · Cook, Inc. · Nov 1985
ABCO SUCTION CANISTER
K851316 · Abco Dealers, Inc. · May 1985
THORAX-KLEX CHEST DRAINAGE UNIT
K830671 · C.R. Bard, Inc. · Mar 1983
VAC-RITE SUNCTION COLLECTION
K811192 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1981
ARGYLE SUCTION CANISTER W/DISP. LINER
K802174 · Sherwood Medical Co. · Sep 1980