# K220363: VPS Rhythm DLX Device with TipTracker Technology

- Pathway: 510(k) (Traditional)
- Applicant: Arrow International, LLC (A subsidiary of Teleflex, Inc.)
- Decided: Aug 22, 2022 after 195 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). 36 ancestors in all.
No later device cites it as a predicate yet.
1 of 37 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) Summary page 4.

## Indications for use
The VPS Rhythm® DLX Device is indicated for the positioning of central venous catheters including PICCs. It provides real-time catheter tip location information by using the patient's cardiac electrical activity. The VPS Rhythm DLX® Device 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. The TipTracker™ Technology is an optional accessory for use with the VPS Rhythm® DLX Device, indicated for visual navigation of a peripherally inserted central catheter (PICC) as it is threaded through the vasculature. The TipTracker™ technology is used for catheter tip navigation purposes only; it is not used to determine final catheter tip placement. For a catheter insertion procedure, ultrasound may optionally be used to assess the blood vessel to aid in selection of catheter size and visualize the blood vessel during initial insertion. Note: In general, devices that utilize ECG technique to observe P-wave are 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 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/K220363
Methodology: https://510kreport.com/methodology