Cleared Special

PM2? System with ECGuide? Connector

K252792 · Piccolo Medical, Inc. · Cardiovascular
Nov 2025
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K252792 is an FDA 510(k) clearance for the PM2? System with ECGuide? Connector, a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II — Special Controls, product code LJS), submitted by Piccolo Medical, Inc. (San Francisco, US). The FDA issued a Cleared decision on November 17, 2025, 76 days after receiving the submission on September 2, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K252792 FDA.gov
FDA Decision Cleared SESE
Date Received September 02, 2025
Decision Date November 17, 2025
Days to Decision 76 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

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

Similar Devices — LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

All 300
BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology
K252373 · Spectrum Vascular · Dec 2025
HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); 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
K243458 · Access Vascular, Inc. · Aug 2025
Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)
K251212 · Access Vascular, Inc. · Jul 2025
PM2+ System and SmartPICC Stylet
K243484 · Piccolo Medical, Inc. · May 2025
pilot TLS
K241587 · Vygon Corporation · Feb 2025
Neonav ECG Tip Location System
K241910 · Navi Medical Technologies · Jan 2025