# K200037: Piccolo Medical SmartPICC System

- Pathway: 510(k) (Traditional)
- Applicant: Piccolo Medical, Inc.
- Decided: Jan 22, 2021 after 380 days
- Product code: LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5970
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K001901 (2000). 34 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142889: Celerity PICC Tip Confirmation System, AngioDynamics, Inc. (2015) Summary page 4.

## Most influential descendants
- K240486: PM2 System and ECGuide Connector (2024), 2 descendants of its own
- K252792: PM2™ System with ECGuide™ Connector (2025), 0 descendants of its own
- K243484: PM2+ System and SmartPICC Stylet (2025), 0 descendants of its own

## Indications for use
The Piccolo Medical SmartPICC System is indicated in adult patients for the positioning of Peripherally Inserted Central Catheters (PICC) with minimum lumen diameter of 0.021”. The SmartPICC system provides real-time catheter tip location information by using the patient’s cardiac electrical activity (intravascular ECG signal). The SmartPICC system is indicated for use as an alternative method to chest x-ray or fluoroscopy confirmation of PICC tip placement in adult patients when proper ECG detection is available. The SmartPICC system includes a supplemental intravascular ionic dilution feature that provides qualitative blood flow information to the user to aid catheter navigation. Note: Use of the intravascular ECG (ivECG) technique to replace x-ray/fluoroscopy confirmation of tip placement is limited, but not contraindicated, for patients where alterations of cardiac rhythm change the presentation of the P-wave such as in atrial fibrillation, atrial flutter, severe tachycardia, pacemaker driven rhythm, and chronic obstructive pulmonary disease (COPD). In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional confirmation method (x-ray or fluoroscopy) is required to confirm catheter tip location.

Source page: https://510kreport.com/device/K200037
Methodology: https://510kreport.com/methodology