Cleared Traditional

K192246 - Biowy PICC Catheter S Kit

K192246 is an FDA 510(k) clearance for Biowy PICC Catheter S Kit, manufactured by Biowy Corporation. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K192246 · Biowy Corporation · General Hospital
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Apr 2020
Decision
255d
Days
Class 2
Risk

K192246 is an FDA 510(k) clearance for the Biowy PICC Catheter S Kit. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Biowy Corporation (Lake Forest, US). The FDA issued a Cleared decision on April 30, 2020 after a review of 255 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - 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 Biowy Corporation devices

FDA 510(k) Submission Details - K192246

510(k) Number K192246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2019
Decision Date April 30, 2020
Days to Decision 255 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
126d slower than avg
Panel avg: 129d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJS Device Classification - Class 2, Special Controls

Product Code LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5970
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 - LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

All 197
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K192246.
BD PowerPiCC Catheter
K210264 · Bard Access Systems, Inc. · Jul 2021
Groshong NXT PICC Catheter
K201452 · C.R. Bard, Inc. · Mar 2021
Piccolo Medical SmartPICC System
K200037 · Piccolo Medical, Inc. · Jan 2021
HydroPICC (PICC-142)
K193015 · Access Vascular, Inc. · Feb 2020
Jet Power Injectable PICC
K180546 · Jet Medical, Inc. · Nov 2018
5 FR Dual Lumen Piper PICC
K181904 · Piper Access, LLC · Sep 2018