Cleared Traditional

K200037 - Piccolo Medical SmartPICC System (FDA 510(k) Clearance)

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

K200037 · Piccolo Medical, Inc. · Cardiovascular device
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Jan 2021
Decision
380d
Days
Class 2
Risk

K200037 is an FDA 510(k) clearance for the Piccolo Medical SmartPICC System. 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 January 22, 2021 after a review of 380 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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

Submission Details

510(k) Number K200037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2020
Decision Date January 22, 2021
Days to Decision 380 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
255d slower than avg
Panel avg: 125d · This submission: 380d
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 Cardiovascular devices follow this clearance model.

Regulatory Consultant

Arina Consulting
Allison Kumar

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K200037.
Neonav ECG Tip Location System
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K252373 · Spectrum Vascular · Dec 2025
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K252792 · Piccolo Medical, Inc. · Nov 2025
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K243458 · Access Vascular, Inc. · Aug 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