Cleared Traditional

K932327 - THORA-KLEX 350 ML PEDIATRIC CHEST DRAIN...

K932327 is the FDA 510(k) clearance for THORA-KLEX 350 ML PEDIATRIC CHEST DRAIN... by Davol, Inc.. It is a Class 2 General Hospital device (product code KDQ) cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K932327 · Davol, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
61d
Days
Class 2
Risk

K932327 is an FDA 510(k) clearance for the THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM. Classified as Bottle, Collection, Vacuum (product code KDQ), Class II - Special Controls.

Submitted by Davol, Inc. (Cranston, US). The FDA issued a Cleared decision on July 13, 1993 after a review of 61 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 Davol, Inc. devices

Submission Details

510(k) Number K932327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1993
Decision Date July 13, 1993
Days to Decision 61 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
68d faster than avg
Panel avg: 129d · This submission: 61d
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 29
Devices cleared under the same product code (KDQ) and FDA review panel - the closest regulatory comparables to K932327.
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
ATRIUM DRY SUCTION CONTROL WATER SEAL CHEST DRAIN
K950677 · Atrium Medical Corp. · Apr 1995
ATRIUM 2000 CHEST DRAIN
K912704 · Atrium Medical Corp. · Aug 1991
PLEUR-EVAC CHEST DRAINAGE SYSTEMS
K905768 · Deknatel, Inc. · Feb 1991
ATRIUM 2000, CHEST DRAIN
K897125 · Atrium Medical Corp. · Mar 1990