510(k) · Decided
DecidedRocket Platinum Cured Cathter
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 Sep 9, 2021 as substantially equivalent to K123033 (Rocket Medical Plc, 2013) and 1 other predicate after a 199-day review. Its family tree reaches back 5 generations to 1997.
- Decided
- Sep 9, 2021
- Review
- 199 days
- Class
- Class II
- Product code
- DWM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K971753 (1997). 11 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 deviceK210509 Rocket Platinum Cured CathterRocket Medical Plc · 2021
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) | K210509 | Rocket Platinum Cured Cathter | Rocket Medical Plc | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2005 | 3 | 0 |
| 2016 | 1 | 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
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 5…is claimed to be substantially equivalent to the following legally marketed predicate devices: 3.1.1 Rocket Indwelling Pleural Catheter (IPC) System (K123033) & Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit (K152105). Verification and validation of the… | 2013 |
| * | K152105 | Rocket IPC Insertion Set, Rocket IPC Mini Insertion SetSummary page 5…arketed predicate devices: 3.1.1 Rocket Indwelling Pleural Catheter (IPC) System (K123033) & Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit (K152105). Verification and validation of the Rocket IPC Platinum Cured Catheter was performed through extensive ben… | 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 24 years and passes through 5 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 11 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. 2021, 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 IPC Platinum Cured Catheter is indicated for intermittent, long-term drainage of symptomatic, recurrent, effusion or ascites, including malignant effusion or ascites and other recurrent effusions or ascites that do not respond to medical management of underlying disease. This device should only be used by or under the supervision of trained personnel and in conjunction with current clinical practice.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210509 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210509: Rocket Platinum Cured Cathter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210509
Report an extraction error
Are you the manufacturer?
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