# K243484: PM2+ System and SmartPICC Stylet

- Pathway: 510(k) (Traditional)
- Applicant: Piccolo Medical, Inc.
- Decided: May 29, 2025 after 202 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: 14 generations back to K001901 (2000). 42 ancestors in all.
No later device cites it as a predicate yet.
2 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200037: Piccolo Medical SmartPICC System, Piccolo Medical, Inc. (2021) Summary page 5.
- K240486: PM2 System and ECGuide Connector, Piccolo Medical, Inc. (2024) Summary page 5.
- K201286: 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch, Nurse Assist, LLC (2020) Summary page 5.

## Indications for use
The PM2+ System and SmartPICC Stylet is indicated for guidance and positioning of commercially available central venous catheters. The Stylet provides stiffness for use in placement of the catheter, intravascular capability for ECG detection and recording for catheter guiding and positioning, and intravascular ionic dilution for supplemental catheter navigation. The SmartPICC Stylet, when used with the PM2+ System, provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. When relying on the patient’s ECG signal, the PM2+ System and SmartPICC Stylet is indicated for use as an alternative method to fluoroscopy or chest x-ray for central venous catheter tip placement confirmation in adult patients. The SmartPICC Stylet is indicated for use with PICC lines having a minimum lumen diameter of 0.0217, Limiting but not contraindicated situations for this technique are in patients where alterations of cardiac rhythm change the presentation of the P-wave as in atrial fibrillation, atrial flutter, severe tachycardia and pacemaker driven rhythm. In such patients, who are easily identifiable prior to central venous catheter insertion the use of an additional method is required to confirm catheter tip location.

Source page: https://510kreport.com/device/K243484
Methodology: https://510kreport.com/methodology