Cleared Traditional

K896697 - PLEUR-EVAC A-6020--INFANT SINGLE USE CH...

K896697 is an FDA 510(k) clearance for PLEUR-EVAC A-6020--INFANT SINGLE USE CH..., 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 72-day FDA review.

K896697 · Deknatel, Inc. · General Hospital
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Feb 1990
Decision
72d
Days
Class 2
Risk

K896697 is an FDA 510(k) clearance for the PLEUR-EVAC(R) A-6020--INFANT SINGLE USE CHEST DRAI. Classified as Bottle, Collection, Vacuum (product code KDQ), Class II - Special Controls.

Submitted by Deknatel, Inc. (San Jose-Heredia, CR). The FDA issued a Cleared decision on February 8, 1990 after a review of 72 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 - K896697

510(k) Number K896697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1989
Decision Date February 08, 1990
Days to Decision 72 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 129d · This submission: 72d
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 K896697.
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
THORA-KLEX CHEST DRAINAGE UNIT
K896127 · Davol, Inc. · Jan 1990
PLEUR-EVAC A-8002--ADULT/PEDIATRIC DUAL COLLECTION
K892915 · Deknatel, Inc. · Jun 1989
PLEUR-EVAC-A-7000--ADULT/PEDI CHEST DRAINAGE SYST
K882223 · Deknatel, Inc. · Aug 1988