Cleared Traditional

K881252 - PLEUR-EVAC A6000 ADULT/PEDIATRIC CHEST ...

K881252 is an FDA 510(k) clearance for PLEUR-EVAC A6000 ADULT/PEDIATRIC CHEST ..., manufactured by Deknatel, Inc.. The device is a Class 2 General Hospital device with product code GCX cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K881252 · Deknatel, Inc. · General Hospital
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Jun 1988
Decision
86d
Days
Class 2
Risk

K881252 is an FDA 510(k) clearance for the PLEUR-EVAC(R) A6000 ADULT/PEDIATRIC CHEST DRAINAGE. Classified as Apparatus, Suction, Operating-room, Wall Vacuum Powered (product code GCX), Class II - Special Controls.

Submitted by Deknatel, Inc. (Lake Success, US). The FDA issued a Cleared decision on June 17, 1988 after a review of 86 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 - K881252

510(k) Number K881252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1988
Decision Date June 17, 1988
Days to Decision 86 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
43d faster than avg
Panel avg: 129d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCX Device Classification - Class 2, Special Controls

Product Code GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered
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 - GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered

All 50
Devices cleared under the same product code (GCX) and FDA review panel - the closest regulatory comparables to K881252.
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