Cleared Traditional

K213550 - HydroPICC 5F Dual Lumen Catheter

K213550 is an FDA 510(k) clearance for HydroPICC 5F Dual Lumen Catheter, manufactured by Access Vascular, Inc.. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K213550 · Access Vascular, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2022
Decision
177d
Days
Class 2
Risk

K213550 is an FDA 510(k) clearance for the HydroPICC 5F Dual Lumen Catheter. 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 May 4, 2022 after a review of 177 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 Access Vascular, Inc. devices

FDA 510(k) Submission Details - K213550

510(k) Number K213550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2021
Decision Date May 04, 2022
Days to Decision 177 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
48d slower than avg
Panel avg: 129d · This submission: 177d
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 193
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K213550.
CATHTONG™ II PICC Catheter
K232594 · L&Z Us, Inc. · Sep 2023
Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly
K222232 · Bard Access Systems, Inc. · Aug 2022
VPS Rhythm DLX Device with TipTracker Technology
K220363 · Arrow International, LLC (A subsidiary of Teleflex, Inc.) · Aug 2022
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