Cleared Traditional

K882223 - PLEUR-EVAC-A-7000--ADULT/PEDI CHEST DRA...

K882223 is an FDA 510(k) clearance for PLEUR-EVAC-A-7000--ADULT/PEDI CHEST DRA..., 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 82-day FDA review.

K882223 · Deknatel, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1988
Decision
82d
Days
Class 2
Risk

K882223 is an FDA 510(k) clearance for the PLEUR-EVAC-A-7000--ADULT/PEDI CHEST DRAINAGE SYST. Classified as Bottle, Collection, Vacuum (product code KDQ), Class II - Special Controls.

Submitted by Deknatel, Inc. (Lake Success, US). The FDA issued a Cleared decision on August 16, 1988 after a review of 82 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 - K882223

510(k) Number K882223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1988
Decision Date August 16, 1988
Days to Decision 82 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
47d faster than avg
Panel avg: 129d · This submission: 82d
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 K882223.
PLEUR-EVAC(R) A-6020--INFANT SINGLE USE CHEST DRAI
K896697 · Deknatel, Inc. · Feb 1990
THORA-KLEX CHEST DRAINAGE UNIT
K896127 · Davol, Inc. · Jan 1990
PLEUR-EVAC A-8002--ADULT/PEDIATRIC DUAL COLLECTION
K892915 · Deknatel, Inc. · Jun 1989
MUCUS TRAP OR SUCTION TRAP
K881149 · Ferguson Medical · Jun 1988
URESIL THORACIC VENT
K863561 · Uresil Corp. · Sep 1986
T-VAC PLEURAL DRAINAGE UNIT, 7800 SERIES
K861025 · Boehringer Laboratories · Apr 1986