Cleared Traditional

K243484 - PM2+ System and SmartPICC Stylet

K243484 is an FDA 510(k) clearance for PM2+ System and SmartPICC Stylet, manufactured by Piccolo Medical, Inc.. The device is a Class 2 Cardiovascular device with product code LJS cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K243484 · Piccolo Medical, Inc. · Cardiovascular device
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May 2025
Decision
202d
Days
Class 2
Risk

K243484 is an FDA 510(k) clearance for the PM2+ System and SmartPICC Stylet. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Piccolo Medical, Inc. (San Francisco, US). The FDA issued a Cleared decision on May 29, 2025 after a review of 202 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 880.5970 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Piccolo Medical, Inc. devices

FDA 510(k) Submission Details - K243484

510(k) Number K243484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2024
Decision Date May 29, 2025
Days to Decision 202 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 125d · This submission: 202d
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 Cardiovascular 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 K243484.
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