# K252792: PM2™ System with ECGuide™ Connector

- Pathway: 510(k) (Special)
- Applicant: Piccolo Medical, Inc.
- Decided: Nov 17, 2025 after 76 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). 44 ancestors in all.
No later device cites it as a predicate yet.
1 of 45 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241910: Neonav ECG Tip Location System, Navi Medical Technologies (2025) Summary page 5.
- K240486: PM2 System and ECGuide Connector, Piccolo Medical, Inc. (2024) Summary page 5.
- K180560: Sherlock 3CG+ T ip Confirmation System, C.R. Bard, Inc. (2018) Summary page 5.

## Indications for use
The PM2™ System with ECGuide™ Connector is indicated for the positioning of central venous access devices (CVADs) of at least 1Fr in size. 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 all central venous access devices. In adult patients and in adolescents (greater than 12 through 21 years of age), The ECGuide™ can be used with CVADs such as peripherally inserted central catheters (PICCs), centrally inserted central catheters (CICCs), implantable ports, and hemodialysis catheters; in children (greater than 2 to 12 years of age), ECGuide™ can be used with PICCs and with CICCs; in infants (greater than 1 month to 2 years of age) and in neonates (from birth to 1 month of age), ECGuide™ can be used with PICCs and CICCs. In each specific age group, the CVAD type and size must be chosen and the CVAD must be used according to the CVAD’s indications and instructions for use. 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/K252792
Methodology: https://510kreport.com/methodology