Cleared Traditional

K873465 - VAN DELLEN BACTERIA FILTER

K873465 is the FDA 510(k) clearance for VAN DELLEN BACTERIA FILTER by Van Dellen, Ltd.. It is a Class 2 General Hospital device (product code FPK) cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K873465 · Van Dellen, Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1988
Decision
145d
Days
Class 2
Risk

K873465 is an FDA 510(k) clearance for the VAN DELLEN BACTERIA FILTER. Classified as Tubing, Fluid Delivery (product code FPK), Class II - Special Controls.

Submitted by Van Dellen, Ltd. (Tucson, US). The FDA issued a Cleared decision on January 20, 1988 after a review of 145 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Van Dellen, Ltd. devices

Submission Details

510(k) Number K873465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1987
Decision Date January 20, 1988
Days to Decision 145 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
16d slower than avg
Panel avg: 129d · This submission: 145d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPK Tubing, Fluid Delivery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPK Tubing, Fluid Delivery

All 21
Devices cleared under the same product code (FPK) and FDA review panel - the closest regulatory comparables to K873465.
INTRAVASCULAR ADMINISTRATION SET MODEL 60040
K891009 · 3M Company · May 1989
INTRAVASCULAR ADMINI. SET MODELS 60030 & 60050
K891005 · 3M Company · May 1989
MERIT HI-FLEX(TM)
K883718 · Merit Medical Systems, Inc. · Jan 1989
INFUSION MANIFOLD
K873852 · Advanced Surgical Products, Inc. · Nov 1987
EXTENSION TUBE PUMP SET
K871085 · Churchill Corp. · Jun 1987
CHURCHILL EXTENSION TUBE
K861626 · Churchill Corp. · Jun 1986