Cleared Traditional

K243458 - HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301) (FDA 510(k) Clearance)

Also includes:
HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302) HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304) HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301) HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302) HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304) Hydr

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

K243458 · Access Vascular, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2025
Decision
266d
Days
Class 2
Risk

K243458 is an FDA 510(k) clearance for the HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (700.... Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Access Vascular, Inc. (Ballerica, US). The FDA issued a Cleared decision on August 1, 2025 after a review of 266 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

Submission Details

510(k) Number K243458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2024
Decision Date August 01, 2025
Days to Decision 266 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
138d slower than avg
Panel avg: 128d · This submission: 266d
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 301
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K243458.
Neonav ECG Tip Location System
K260929 · Navi Medical Technologies · Apr 2026
BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology
K252373 · Spectrum Vascular · Dec 2025
PM2™ System with ECGuide™ Connector
K252792 · Piccolo Medical, Inc. · Nov 2025
Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM)
K251212 · Access Vascular, Inc. · Jul 2025
PM2+ System and SmartPICC Stylet
K243484 · Piccolo Medical, Inc. · May 2025
pilot TLS
K241587 · Vygon Corporation · Feb 2025