Cleared Traditional

K801602 - DESERET I.V. FILTER

K801602 is the FDA 510(k) clearance for DESERET I.V. FILTER by Hospital Products Co.. It is a Class 2 General Hospital device (product code FPB) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K801602 · Hospital Products Co. · General Hospital
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Aug 1980
Decision
44d
Days
Class 2
Risk

K801602 is an FDA 510(k) clearance for the DESERET I.V. FILTER. Classified as Filter, Infusion Line (product code FPB), Class II - Special Controls.

Submitted by Hospital Products Co. (Mchenry, US). The FDA issued a Cleared decision on August 27, 1980 after a review of 44 days - a notably fast clearance cycle.

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: 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 Hospital Products Co. devices

Submission Details

510(k) Number K801602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1980
Decision Date August 27, 1980
Days to Decision 44 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
85d faster than avg
Panel avg: 129d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPB Filter, Infusion Line
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 - FPB Filter, Infusion Line

All 54
Devices cleared under the same product code (FPB) and FDA review panel - the closest regulatory comparables to K801602.
BACTAGARD
K811773 · Tri-Med, Inc. · Jul 1981
TERFUSION FINAL FILTER SET
K810113 · Terumo Medical Corp. · Mar 1981
ACRODISC FILTER ASSEMBLY
K802765 · Gelman Sciences, Inc. · Jan 1981
MODEL 40-30-2 AIR ELIMINATING FILTER SET
K801614 · Y · Aug 1980
BIMECO FILTERED EXTENSION SET
K801605 · Burron Medical Products, Inc. · Aug 1980
B-D FILTER NEEDLE
K801343 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1980