Cleared Traditional

K962856 - PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST...

K962856 is an FDA 510(k) clearance for PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST..., manufactured by Deknatel, Inc.. The device is a Class 2 General Hospital device with product code KDQ cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K962856 · Deknatel, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
37d
Days
Class 2
Risk

K962856 is an FDA 510(k) clearance for the PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200,.... Classified as Bottle, Collection, Vacuum (product code KDQ), Class II - Special Controls.

Submitted by Deknatel, Inc. (Fall River, US). The FDA issued a Cleared decision on August 28, 1996 after a review of 37 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 Deknatel, Inc. devices

FDA 510(k) Submission Details - K962856

510(k) Number K962856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1996
Decision Date August 28, 1996
Days to Decision 37 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
92d faster than avg
Panel avg: 129d · This submission: 37d
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 K962856.
EXPRESS CHEST DRAIN
K081718 · Atrium Medical Corp. · Jul 2008
OCEAN CHEST DRAIN
K043582 · Atrium Medical Corp. · Jan 2005
ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN
K984496 · Atrium Medical Corp. · May 1999
MUCUS SPECIMEN TRAP
K962168 · Sage Products, Inc. · Jul 1996
ATRIUM DRY SUCTION CONTROL WATER SEAL CHEST DRAIN
K950677 · Atrium Medical Corp. · Apr 1995
PM9000 VAC TRAP
K941818 · Precision Medical, Inc. · Dec 1994