Cleared Traditional

K801605 - BIMECO FILTERED EXTENSION SET

K801605 is the FDA 510(k) clearance for BIMECO FILTERED EXTENSION SET by Burron Medical Products, Inc.. It is a Class 2 General Hospital device (product code FPB) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K801605 · Burron Medical Products, Inc. · General Hospital
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Aug 1980
Decision
28d
Days
Class 2
Risk

K801605 is an FDA 510(k) clearance for the BIMECO FILTERED EXTENSION SET. Classified as Filter, Infusion Line (product code FPB), Class II - Special Controls.

Submitted by Burron Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 12, 1980 after a review of 28 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 Burron Medical Products, Inc. devices

Submission Details

510(k) Number K801605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1980
Decision Date August 12, 1980
Days to Decision 28 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
101d faster than avg
Panel avg: 129d · This submission: 28d
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 28
Devices cleared under the same product code (FPB) and FDA review panel - the closest regulatory comparables to K801605.
IVEX-HP PEDIATRIC EXTENSION SET-SL
K821013 · Abbott Laboratories · Jul 1982
TERFUSION FINAL FILTER SET
K810113 · Terumo Medical Corp. · Mar 1981
MODEL 40-30-2 AIR ELIMINATING FILTER SET
K801614 · Y · Aug 1980
B-D FILTER NEEDLE
K801343 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1980
BIOGUARD INFUSION LINE FILTER
K791822 · United States Surgical, A Division of Tyco Healthc · Nov 1979
FILTERSET W/Y-INJECTION SITE, 0.2
K772312 · Abbott Laboratories · Jan 1978