# K152261: PICC Tip Positioning Aid

- Pathway: 510(k) (Traditional)
- Applicant: Nostix, LLC
- Decided: Oct 21, 2015 after 71 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.
5 later devices descend from it; 1 cites 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)
- K142889: Celerity PICC Tip Confirmation System, AngioDynamics, Inc. (2015) Summary page 4.

## Most influential descendants
- K160925: VPS Rhythm Device with TipTracker Technology (2016), 4 descendants of its own
- 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
- K220363: VPS Rhythm DLX Device with TipTracker Technology (2022), 0 descendants of its own

## Indications for use
The PICC Tip Positioning Aid is indicated for the positioning of Peripherally Inserted Central Catheters (P1CC) in adult patients. It provides real-time catheter tip location information by using the patient's cardiac electrical activity. The PICC Tip Positioning Aid is indicated for use as an alternative method to chest x-ray or fluoroscopy confirmation of PICC tip placement in adult patients. Note: In general, devices that utilize ECG technique to observe P-Wave arc limited, but not contraindicated, for patients where cardiac thythms 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 PICC insertion. Use of an additional confirmation method is necessary to confirm catheter tip location.

Source page: https://510kreport.com/device/K152261
Methodology: https://510kreport.com/methodology