Cleared Traditional

K854634 - BARD PARKER THORACIC VENT

K854634 is the FDA 510(k) clearance for BARD PARKER THORACIC VENT by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 2 General Hospital device (product code KDQ) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K854634 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General Hospital
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Dec 1985
Decision
38d
Days
Class 2
Risk

K854634 is an FDA 510(k) clearance for the BARD PARKER THORACIC VENT. Classified as Bottle, Collection, Vacuum (product code KDQ), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Paramus, US). The FDA issued a Cleared decision on December 27, 1985 after a review of 38 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K854634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1985
Decision Date December 27, 1985
Days to Decision 38 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
91d faster than avg
Panel avg: 129d · This submission: 38d
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 32
Devices cleared under the same product code (KDQ) and FDA review panel - the closest regulatory comparables to K854634.
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
GRECO-HARVEY SURFACTANT BONDED CATH FOR ANESTHESIO
K851244 · Cook, Inc. · Nov 1985
COMPACT 2000
K851892 · Atrium Medical Corp. · Jun 1985
ABCO SUCTION CANISTER
K851316 · Abco Dealers, Inc. · May 1985