510(k) · Decided
Recalled · Class II · 2014Veta Peritoneal Dialysis Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pfm Medical, Inc. · FJS Catheter, Peritoneal, Long-Term Indwelling
Cleared on Mar 13, 2012 as substantially equivalent to K812607 (Quinton, Inc., 1981) and 2 other predicates after a 120-day review. Its family tree reaches back 3 generations to 2001. It has been recalled once.
- Decided
- Mar 13, 2012
- Review
- 120 days
- Class
- Class II
- Product code
- FJS
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K010642 (2001). 8 ancestors in all, the oldest K812607 (1981). No later device cites it as a predicate yet.
- Root · 3 generations backK010642 Pleurx Pleural Catheter and Drainage KitsDenver Biomedicals, Inc. · 2001
- 2 generations backK093307 Asept Pleural Drainage SystemPfm Medical, Inc. · 2009 · Recalled
- 1 generation backK093796 Asept Peritoneal Drainage SystemPfm Medical, Inc. · 2010 · Recalled
- This deviceK113354 Veta Peritoneal Dialysis CatheterPfm Medical, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010642 | Pleurx Pleural Catheter and Drainage Kits | Denver Biomedicals, Inc. | 2001 | — |
| −2 | K093307 | Asept Pleural Drainage System | Pfm Medical, Inc. | 2009 | 2 |
| −1 | K093796 | Asept Peritoneal Drainage System | Pfm Medical, Inc. | 2010 | 1 |
| 0 (this device) | K113354 | Veta Peritoneal Dialysis Catheter | Pfm Medical, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 3 | 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 FJS? 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 FJS device
- #1 K213602 Argyle Peritoneal Dialysis Cathetor and Kit…score 3.0 · 2 generations · no Class I recall
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K812607 | Tenckhoff Peritoneal CathetersSummary page 1…n Name: Peritoneal Dialysis System and Accessories Equivalent Devices: Manufacturer: Quinton, Inc. (now Covidien) Name: Quinton Tenckhoff Peritoneal Catheter 510(k) #: K812607 Manufacturer: PFM Medical, Inc. Name: ASEPT Peritoneal Drainage System 51 0(k) #: K093796 Manufacturer: Denver Biomedical (now… | 1981 |
| * | K093796 | Asept Peritoneal Drainage SystemSummary page 1…ton, Inc. (now Covidien) Name: Quinton Tenckhoff Peritoneal Catheter 510(k) #: K812607 Manufacturer: PFM Medical, Inc. Name: ASEPT Peritoneal Drainage System 51 0(k) #: K093796 Manufacturer: Denver Biomedical (now Cardinal Health) Name: Pleurx Peritonea] Catheter Kit and Pleurx Drainage Kits 510(k) #: K0… | 2010 |
| * | K051711 | Pleurx Peritoneal Catheter Kit and Pleurx Drainage KitsSummary page 1…itoneal Drainage System 51 0(k) #: K093796 Manufacturer: Denver Biomedical (now Cardinal Health) Name: Pleurx Peritonea] Catheter Kit and Pleurx Drainage Kits 510(k) #: K051711 Device Description: Vets T M Peritoneal Dialysis Catheters are side-ported silicone catheters with a single and double retention… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 20, 2014 | Class II | Z-0568-2015 | Process control | PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. |
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 2.0 years on median.
- 2 of the 8 ancestors have a recall of any class.
How does its category compare?
All FJS devicesFJS Catheter, Peritoneal, Long-Term Indwelling: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · FJS
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · FJS
120in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FJS
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FJS
140in 2025
MAUDE reports naming product code FJS, 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 | 2 | — | 0 | 12 |
| 2008 | 0 | — | 0 | 9 |
| 2009 | 0 | — | 0 | 75 |
| 2010 | 0 | — | 0 | 67 |
| 2011 | 0 | — | 4 | 58 |
| 2012 | 3 | 120 | 0 | 37 |
| 2013 | 1 | — | 0 | 84 |
| 2014 | 0 | — | 1 | 66 |
| 2015 | 0 | — | 0 | 61 |
| 2016 | 0 | — | 0 | 38 |
| 2017 | 0 | — | 0 | 75 |
| 2018 | 1 | — | 0 | 137 |
| 2019 | 0 | — | 0 | 53 |
| 2020 | 0 | — | 0 | 94 |
| 2021 | 0 | — | 0 | 78 |
| 2022 | 1 | — | 0 | 102 |
| 2023 | 0 | — | 0 | 619 |
| 2024 | 0 | — | 0 | 149 |
| 2025 | 0 | — | 0 | 140 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Veta Peritoneal Dialysis Catheter is indicated for acute and chronic access to the peritoneal cavity. The Veta Peritoneal Dialysis Catheters will be used to drain and infuse fluid during peritoneal dialysis procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113354 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113354: Veta Peritoneal Dialysis Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113354
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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