Cleared Traditional

K892915 - PLEUR-EVAC A-8002--ADULT/PEDIATRIC DUAL COLLECTION (FDA 510(k) Clearance)

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

K892915 · Deknatel, Inc. · General Hospital
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Jun 1989
Decision
62d
Days
Class 2
Risk

K892915 is an FDA 510(k) clearance for the PLEUR-EVAC A-8002--ADULT/PEDIATRIC DUAL COLLECTION. 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 June 21, 1989 after a review of 62 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

Submission Details

510(k) Number K892915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1989
Decision Date June 21, 1989
Days to Decision 62 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 128d · This submission: 62d
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.