Cleared Traditional

HydroPICC (PICC-142) (K193015) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K193015 · Access Vascular, Inc. · General Hospital
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Feb 2020
Decision
114d
Days
Class 2
Risk

K193015 is an FDA 510(k) clearance for the HydroPICC (PICC-142). Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Access Vascular, Inc. (Bedford, US). The FDA issued a Cleared decision on February 20, 2020 after a review of 114 days - within the typical 510(k) review window.

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 Access Vascular, Inc. devices

Submission Details

510(k) Number K193015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2019
Decision Date February 20, 2020
Days to Decision 114 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
15d faster than avg
Panel avg: 129d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 89
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K193015.
Groshong NXT PICC Catheter
K201452 · C.R. Bard, Inc. · Mar 2021
Piccolo Medical SmartPICC System
K200037 · Piccolo Medical, Inc. · Jan 2021
Biowy PICC Catheter S Kit
K192246 · Biowy Corporation · Apr 2020
Jet Power Injectable PICC
K180546 · Jet Medical, Inc. · Nov 2018
5 FR Dual Lumen Piper PICC
K181904 · Piper Access, LLC · Sep 2018
Sherlock 3CG+ T ip Confirmation System
K180560 · C.R. Bard, Inc. · Jun 2018