Cleared Traditional

K161866 - BioFlo Midline Catheter

K161866 is the FDA 510(k) clearance for BioFlo Midline Catheter by Navilyst Medical, Inc.. It is a Class 2 General Hospital device (product code FOZ) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K161866 · Navilyst Medical, Inc. · General Hospital
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Sep 2016
Decision
63d
Days
Class 2
Risk

K161866 is an FDA 510(k) clearance for the BioFlo Midline Catheter. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Navilyst Medical, Inc. (Marlborough, US). The FDA issued a Cleared decision on September 8, 2016 after a review of 63 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 Navilyst Medical, Inc. devices

Submission Details

510(k) Number K161866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2016
Decision Date September 08, 2016
Days to Decision 63 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 129d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 240
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K161866.
BD Nexiva Diffusics Closed IV Catheter System
K170283 · Becton, Dickinson and Company · Feb 2017
AccuCath Intravascular Catheter
K162894 · C.R. Bard, Inc. · Nov 2016
PowerGlide Pro Midline Catheter
K162377 · C.R. Bard, Inc. · Sep 2016
BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems
K161777 · Becton Dickinson Infusion Therapy Systems, Inc. · Aug 2016
ViaValve Safety I.V. Catheter
K160235 · Smiths Medical Asd, Inc. · Jun 2016
PowerGlide Pro Midline Catheter
K153280 · C.R. Bard, Inc. · Jun 2016