Cleared Traditional

K851101 - BIONOMY'S MULTI-LUMEN CENTRAL VENOUS CATHETER-SET

K851101 is an FDA 510(k) clearance for BIONOMY'S MULTI-LUMEN CENTRAL VENOUS CA..., manufactured by Bionomy, Inc.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K851101 · Bionomy, Inc. · General Hospital
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Apr 1985
Decision
24d
Days
Class 2
Risk

K851101 is an FDA 510(k) clearance for the BIONOMY'S MULTI-LUMEN CENTRAL VENOUS CATHETER-SET. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Bionomy, Inc. (Tampa, US). The FDA issued a Cleared decision on April 12, 1985 after a review of 24 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - 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 Bionomy, Inc. devices

FDA 510(k) Submission Details - K851101

510(k) Number K851101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1985
Decision Date April 12, 1985
Days to Decision 24 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
105d faster than avg
Panel avg: 129d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FOZ Device Classification - Class 2, Special Controls

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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 - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 428
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K851101.
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DESERET INTRAVASCULAR CATHETER
K843033 · Parke-Davis Co. · Dec 1984
DESERET SUBCLAVIAN JUGULAR CATHETER SET
K844113 · Parke-Davis Co. · Nov 1984