Cleared Traditional

K873463 - VAN DELLEN ASPIRATING TUBING

K873463 is the FDA 510(k) clearance for VAN DELLEN ASPIRATING TUBING by Van Dellen, Ltd.. It is a Class 2 General Hospital device (product code BYY) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K873463 · Van Dellen, Ltd. · General Hospital
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Nov 1987
Decision
87d
Days
Class 2
Risk

K873463 is an FDA 510(k) clearance for the VAN DELLEN ASPIRATING TUBING. Classified as Tube, Aspirating, Flexible, Connecting (product code BYY), Class II - Special Controls.

Submitted by Van Dellen, Ltd. (Tucson, US). The FDA issued a Cleared decision on November 23, 1987 after a review of 87 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 Van Dellen, Ltd. devices

Submission Details

510(k) Number K873463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1987
Decision Date November 23, 1987
Days to Decision 87 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 129d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BYY Tube, Aspirating, Flexible, Connecting
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 - BYY Tube, Aspirating, Flexible, Connecting

All 8
Devices cleared under the same product code (BYY) and FDA review panel - the closest regulatory comparables to K873463.
GENERAL HOSPITAL TUBING CLAMP (NON-ELECTRIC)
K911586 · Megadyne Medical Products, Inc. · Jul 1991
FLEX BUBBLE TUBING
K832865 · Sheridan Catheter Corp. · Sep 1983
DYNACOR CONNECTING TUBING
K832398 · Medline Industries, Inc. · Aug 1983
PLASTIC CONNECTORS
K820371 · American Pharmaseal Div. Ahsc · Apr 1982
AM. PH. STERILE PLASTIC CONNECTING TUBES
K820412 · American Pharmaseal Div. Ahsc · Mar 1982
ABCO CONNECTING TUBES PRECUT LENGTHS
K800235 · Abco Dealers, Inc. · Feb 1980