510(k) · Cleared
ClearedRocket Indwelling Pleural Catheter (IPC) Insertion Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rocket Medical Plc · DWM Apparatus, Suction, Patient Care
Cleared on Aug 17, 2017 as substantially equivalent to K123033 (Rocket Medical Plc, 2013) and 1 other predicate after a 265-day review. Its family tree reaches back 5 generations to 1997.
- Decided
- Aug 17, 2017
- Review
- 265 days
- Class
- Class II
- Product code
- DWM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K971753 (1997). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK971753 Denver Pleurx Pleural Catheter Kit, Catalog NO. 50-7000, Denver…Denver Biomaterials, Inc. · 1997
- 4 generations backK071095 Aspira Pleural Drainage SystemBard Access Systems, Inc. · 2007
- 3 generations backK110409 Aspira Pleural Drainage SystemC.R. Bard, Inc. · 2011 · Recalled
- 2 generations backK112831 Pleurx Pleural Catheter SystemsCare Fusion · 2012
- 1 generation backK123033 Rocket Ipc Insertion Pack, Rocket Ipc Mini Insertion Set, Rocket Ipc…Rocket Medical Plc · 2013
- This deviceK163321 Rocket Indwelling Pleural Catheter (IPC) Insertion KitRocket Medical Plc · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K971753 | Denver Pleurx Pleural Catheter Kit, Catalog NO. 50-7000, Denver Pleurx Home… | Denver Biomaterials, Inc. | 1997 | — |
| −4 | K071095 | Aspira Pleural Drainage System | Bard Access Systems, Inc. | 2007 | — |
| −3 | K110409 | Aspira Pleural Drainage System | C.R. Bard, Inc. | 2011 | 1 |
| −2 | K112831 | Pleurx Pleural Catheter Systems | Care Fusion | 2012 | — |
| −1 | K123033 | Rocket Ipc Insertion Pack, Rocket Ipc Mini Insertion Set, Rocket Ipc Dressing… | Rocket Medical Plc | 2013 | — |
| 0 (this device) | K163321 | Rocket Indwelling Pleural Catheter (IPC) Insertion Kit | Rocket Medical Plc | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2005 | 3 | 0 |
| 2016 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DWM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DWM device
- #1 K212696 Aspira Pleural Drainage Systemscore 5.5 · 3 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K123033 | Rocket Ipc Insertion Pack, Rocket Ipc Mini Insertion Set, Rocket Ipc Dressing Pack and…Summary page 4…ivalent to the following devices: Device(s): o Predicate: Rocket Indwelling Pleural Catheter (IPC) Insertion Kit; (Rocket Medical PLC, K123033) o Reference Predicate: Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit;… | 2013 |
| * | K162457 | Rocket Indwelling Peritoneal Catheter (IPC) Insertion KitSummary page 4…edical PLC, K123033) o Reference Predicate: Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit; (Rocket Medical PLC, K162457). This device kit components and accessories are identical to the subject device.… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 5 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 12 ancestors has a recall of any class.
- 1 other device also cites its predicate K123033.
How does its category compare?
All DWM devicesDWM Apparatus, Suction, Patient Care: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · DWM
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · DWM
Too few DWM 510(k)s in any year since 2007 to give a median.
Recalls per year · DWM
2in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DWM
74in 2025
MAUDE reports naming product code DWM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 8 |
| 2011 | 1 | — | 0 | 23 |
| 2012 | 2 | — | 0 | 16 |
| 2013 | 1 | — | 0 | 78 |
| 2014 | 0 | — | 2 | 94 |
| 2015 | 1 | — | 0 | 82 |
| 2016 | 1 | — | 0 | 49 |
| 2017 | 1 | — | 0 | 62 |
| 2018 | 0 | — | 0 | 51 |
| 2019 | 1 | — | 0 | 57 |
| 2020 | 1 | — | 0 | 68 |
| 2021 | 1 | — | 0 | 143 |
| 2022 | 0 | — | 0 | 62 |
| 2023 | 1 | — | 0 | 108 |
| 2024 | 0 | — | 0 | 70 |
| 2025 | 0 | — | 0 | 74 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163321 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163321: Rocket Indwelling Pleural Catheter (IPC) Insertion Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163321
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026