# K142889: Celerity PICC Tip Confirmation System

- Pathway: 510(k) (Traditional)
- Applicant: AngioDynamics, Inc.
- Decided: Jan 27, 2015 after 116 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K001901 (2000). 33 ancestors in all.
8 later devices descend from it; 3 cite it directly.
1 of 42 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140799: Celerity Sysyem, Medcomp (Medical Components, Inc.) (2014) Summary page 4.
- K093775: Evguide Tip Location System, Romedex International Srl (2010) Summary page 4.

## Most influential descendants
- K152261: PICC Tip Positioning Aid (2015), 5 descendants of its own
- K160925: VPS Rhythm Device with TipTracker Technology (2016), 4 descendants of its own
- K200037: Piccolo Medical SmartPICC System (2021), 3 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

## Recalls of this device
- Sep 7, 2016 · Class II · Z-1137-2017: The Celerity ECG Cable Accessory Pack has the potential to contain an ECG Clip Cable that was not properly manufactured. The affected product is not soldered per specification, and may result in the d

## Indications for use
The Celerity System is indicated for the positioning of Peripherally Inserted Central Catheters (PICC) in adult patients. It provides real-time catheter tip location information by using the patient's cardiac electrical activity. The Celerity System 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 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 PICC insertion. Use of an additional confirmation method is necessary o confirm catheter tip location.

Source page: https://510kreport.com/device/K142889
Methodology: https://510kreport.com/methodology