# K240486: PM2 System and ECGuide Connector

- Pathway: 510(k) (Traditional)
- Applicant: Piccolo Medical, Inc.
- Decided: Sep 8, 2024 after 201 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: 13 generations back to K001901 (2000). 37 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 40 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160925: VPS Rhythm Device with TipTracker Technology, Arrow International, Inc. (A Subsidiary of Teleflex, Inc.) (2016)
- K200037: Piccolo Medical SmartPICC System, Piccolo Medical, Inc. (2021) Summary page 5.

## Most influential descendants
- 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 PM2™ System with ECGuide™ Connector is indicated for the positioning of central venous catheters including PICCs. It provides catheter tip location information by using the patient’s cardiac electrical activity. The PM2™ System with ECGuide™ Connector is indicated for use as an alternative method to chest x-ray or fluoroscopy for confirmation of central venous catheter tip placement in adult patients. Note: In general, devices that utilize ECG technique to observe P-wave are limited, but not contraindicated, for patients where cardiac rhythms may change presentation of the P-wave; including -Atrial fibrillation -Atrial flutter -Severe tachycardia -Pacemaker-driven rhythm -Chronic obstructive pulmonary disease (COPD) Such patients are easily identified prior to central catheter insertion. In these specific cases, use of an additional confirmation method is necessary to confirm catheter tip location.

Source page: https://510kreport.com/device/K240486
Methodology: https://510kreport.com/methodology