# K163321: Rocket Indwelling Pleural Catheter (IPC) Insertion Kit

- Pathway: 510(k) (Traditional)
- Applicant: Rocket Medical Plc
- Decided: Aug 17, 2017 after 265 days
- Product code: DWM (Apparatus, Suction, Patient Care)
- Device class: 2
- Regulation: 21 CFR 870.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K971753 (1997). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123033: Rocket Ipc Insertion Pack, Rocket Ipc Mini Insertion Set, Rocket Ipc Dressing Pack and Bottle Set, Rocket Ipc Drainage B, Rocket Medical Plc (2013) Summary page 4.
- K162457: Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit, Rocket Medical Plc (2016) Summary page 4.

## Indications for use
The Rocket Indwelling Pleural Catheter (IPC) Insertion Kit (Model # R51400-16-PL and R51400-MI-PL) is indicated for intermittent, long-term drainage of symptomatic, recurrent, pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond to medical management of underlying disease. The device is indicated for: The palliation of dyspnea due to pleural effusion Providing pleurodesis (resolution of the pleural effusion) This device should only be used by or under the supervision of trained personnel and in conjunction with current clinical practice guidelines.

Source page: https://510kreport.com/device/K163321
Methodology: https://510kreport.com/methodology