Cleared Traditional

K863561 - URESIL THORACIC VENT

K863561 is an FDA 510(k) clearance for URESIL THORACIC VENT, manufactured by Uresil Corp.. The device is a Class 2 General Hospital device with product code KDQ cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K863561 · Uresil Corp. · General Hospital
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Sep 1986
Decision
11d
Days
Class 2
Risk

K863561 is an FDA 510(k) clearance for the URESIL THORACIC VENT. Classified as Bottle, Collection, Vacuum (product code KDQ), Class II - Special Controls.

Submitted by Uresil Corp. (Skokie, US). The FDA issued a Cleared decision on September 23, 1986 after a review of 11 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 Uresil Corp. devices

FDA 510(k) Submission Details - K863561

510(k) Number K863561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1986
Decision Date September 23, 1986
Days to Decision 11 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
118d faster than avg
Panel avg: 129d · This submission: 11d
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 32
Devices cleared under the same product code (KDQ) and FDA review panel - the closest regulatory comparables to K863561.
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
MUCUS TRAP OR SUCTION TRAP
K881149 · Ferguson Medical · Jun 1988
T-VAC PLEURAL DRAINAGE UNIT, 7800 SERIES
K861025 · Boehringer Laboratories · Apr 1986
FILTERED VACUUM SAFETY TRAP BOTTLE
K855074 · Boehringer Laboratories · Mar 1986
COMPACT 2000 WATER SEAL CHEST DRAINAGE UNIT
K860023 · Atrium Medical Corp. · Jan 1986