Cleared Traditional

K855074 - FILTERED VACUUM SAFETY TRAP BOTTLE

K855074 is the FDA 510(k) clearance for FILTERED VACUUM SAFETY TRAP BOTTLE by Boehringer Laboratories. It is a Class 2 General Hospital device (product code KDQ) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K855074 · Boehringer Laboratories · General Hospital
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Mar 1986
Decision
84d
Days
Class 2
Risk

K855074 is an FDA 510(k) clearance for the FILTERED VACUUM SAFETY TRAP BOTTLE. Classified as Bottle, Collection, Vacuum (product code KDQ), Class II - Special Controls.

Submitted by Boehringer Laboratories (Norristown, US). The FDA issued a Cleared decision on March 13, 1986 after a review of 84 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 Boehringer Laboratories devices

Submission Details

510(k) Number K855074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1985
Decision Date March 13, 1986
Days to Decision 84 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
45d faster than avg
Panel avg: 129d · This submission: 84d
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.

Regulatory Peers - KDQ Bottle, Collection, Vacuum

All 29
Devices cleared under the same product code (KDQ) and FDA review panel - the closest regulatory comparables to K855074.
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
COMPACT 2000 WATER SEAL CHEST DRAINAGE UNIT
K860023 · Atrium Medical Corp. · Jan 1986
BARD PARKER THORACIC VENT
K854634 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1985
GRECO-HARVEY SURFACTANT BONDED CATH FOR ANESTHESIO
K851244 · Cook, Inc. · Nov 1985