# K171931: Celerity ECG Cable Accessory Pack

- Pathway: 510(k) (Traditional)
- Applicant: Medcomp (Medical Components, Inc.)
- Decided: Oct 26, 2017 after 120 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.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142889: Celerity PICC Tip Confirmation System, AngioDynamics, Inc. (2015) Summary page 5.

## 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 to confirm catheter tip location.

Source page: https://510kreport.com/device/K171931
Methodology: https://510kreport.com/methodology