510(k) · Decided
DecidedRocket Indwelling Peritoneal Catheter (IPC) Insertion Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rocket Medical Plc · PNG Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
Cleared on Nov 14, 2016 as substantially equivalent to K152105 (Rocket Medical Plc, 2016) after a 73-day review. Its family tree reaches back 2 generations to 2005. 1 later device descends from it.
- Decided
- Nov 14, 2016
- Review
- 73 days
- Class
- Class II
- Product code
- PNG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K051711 (2005). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK051711 Pleurx Peritoneal Catheter Kit and Pleurx Drainage KitsDenver Biomedical, Inc. · 2005
- 1 generation backK152105 Rocket IPC Insertion Set, Rocket IPC Mini Insertion SetRocket Medical Plc · 2016
- This deviceK162457 Rocket Indwelling Peritoneal Catheter (IPC) Insertion KitRocket Medical Plc · 2016
- Descendant · cites it directly · 0 of its ownK163321 Rocket Indwelling Pleural Catheter (IPC) Insertion KitRocket Medical Plc · 2017
Most influential descendants
Showing 1 of 1 · See all- K163321Rocket Indwelling Pleural Catheter (IPC) Insertion KitRocket Medical Plc · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K051711 | Pleurx Peritoneal Catheter Kit and Pleurx Drainage Kits | Denver Biomedical, Inc. | 2005 | — |
| −1 | K152105 | Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set | Rocket Medical Plc | 2016 | — |
| 0 (this device) | K162457 | Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit | Rocket Medical Plc | 2016 | — |
| +1 | K163321 | Rocket Indwelling Pleural Catheter (IPC) Insertion Kit | Rocket Medical Plc | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 PNG? 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 PNG device
- #1 K241946 PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L…score 10.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K152105 | Rocket IPC Insertion Set, Rocket IPC Mini Insertion SetSummary page 5…ce is equivalent to the following device: Device(s): o Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit; (Rocket Medical Plc, K152105) Device The Rocket Indwelling Peritoneal Catheter (IPC) is a fenestrated silicone Description: drainage catheter… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163321 | Rocket Indwelling Pleural Catheter (IPC) Insertion Kit | 2017 | 0 |
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 11 years and passes through 2 companies; a new generation was cleared every 10.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K163321 (Rocket Medical Plc, 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K152105.
How does its category compare?
All PNG devicesPNG Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · PNG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PNG
244in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PNG
No recall names PNG since 2007.
Adverse event reports per year · PNG
31in 2025
MAUDE reports naming product code PNG, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 3 | 244 | 0 | 0 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 6 |
| 2019 | 0 | — | 0 | 9 |
| 2020 | 1 | — | 0 | 15 |
| 2021 | 1 | — | 0 | 15 |
| 2022 | 0 | — | 0 | 18 |
| 2023 | 2 | — | 0 | 21 |
| 2024 | 1 | — | 0 | 18 |
| 2025 | 1 | — | 0 | 31 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit (Model # R51401-16-PT and R51401-MI-PT) contains the following MAJOR components:
x Indwelling Peritoneal Catheter (Model # ZASEM192)
x Drainage Line (Model #R54410-00-DL)
x Accessories for insertion, attachment and dressing
The Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit is indicated for intermittent drainage of symptomatic, recurrent malignant ascites. Also the palliation of symptoms related to recurrent malignant ascites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162457 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162457: Rocket Indwelling Peritoneal 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/K162457
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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