510(k) · Cleared
ClearedAntimicrobial Peritoneal Dialysis Coil Catheter with Spi-Argent II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sil-Med Corp. · FJS Catheter, Peritoneal, Long-Term Indwelling
Cleared on Jul 18, 1997 as substantially equivalent to K850247 (Sil-Med Corp., 1985) and 2 other predicates after a 463-day review. Its family tree reaches back 1 generation to 1985. 1 of the 7 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Jul 18, 1997
- Review
- 463 days
- Class
- Class II
- Product code
- FJS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K850247 (1985). 3 ancestors in all. 3 later devices descend from it, 1 citing it directly. 1 of the 7 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK850247 Peritoneal Dialysis Coil CatheterSil-Med Corp. · 1985
- This deviceK961392 Antimicrobial Peritoneal Dialysis Coil Catheter with Spi-Argent IISil-Med Corp. · 1997
- Descendant · cites it directly · 2 of its ownK012193 Amc Antimicrobial Pin/Wire SleeveSmith & Nephew, Inc. · 2002
- Descendant · 2 generations on · 0 of its ownK022688 Versabond AB Bone CementSmith & Nephew, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 0 of its ownK022676 Orthoguard AB Antimicrobial SleeveSmith & Nephew, Inc. · 2002
Class I recalls in this family
- K900263 Antimicrobial Multi-Lumen Central Venous Catheterdirect predicate · 1990
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K850247 | Peritoneal Dialysis Coil Catheter | Sil-Med Corp. | 1985 | — |
| 0 (this device) | K961392 | Antimicrobial Peritoneal Dialysis Coil Catheter with Spi-Argent II | Sil-Med Corp. | 1997 | — |
| +1 | K012193 | Amc Antimicrobial Pin/Wire Sleeve | Smith & Nephew, Inc. | 2002 | — |
| +2 | K022688 | Versabond AB Bone Cement | Smith & Nephew, Inc. | 2004 | 1 |
| +2 | K022676 | Orthoguard AB Antimicrobial Sleeve | Smith & Nephew, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 1 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2004 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K850247 | Peritoneal Dialysis Coil CatheterSummary page 1…tion to and from the peritoneal cavity for treatment of renal failure; suitable for CAPD (Continuous Ambulatory Peritoneal Dialysis). Peritoneal Dialysis Coil Catheter: K850247 Mediastinal Silicone Drain: K942709 Antimicrobial Multi-Lumen Central Venous Catheter: K900263 Peritoneal Dialysis Coil Catheter… | 1985 |
| * | K942709 | Mediastinal Silicone DrainsSummary page 1…ty for treatment of renal failure; suitable for CAPD (Continuous Ambulatory Peritoneal Dialysis). Peritoneal Dialysis Coil Catheter: K850247 Mediastinal Silicone Drain: K942709 Antimicrobial Multi-Lumen Central Venous Catheter: K900263 Peritoneal Dialysis Coil Catheter with Spi-Argent™ill, for the transp… | 1996 |
| * | K900263 | Antimicrobial Multi-Lumen Central Venous CatheterSummary page 1…nuous Ambulatory Peritoneal Dialysis). Peritoneal Dialysis Coil Catheter: K850247 Mediastinal Silicone Drain: K942709 Antimicrobial Multi-Lumen Central Venous Catheter: K900263 Peritoneal Dialysis Coil Catheter with Spi-Argent™ill, for the transport of dialysate solution to and from the peritoneal cavity… | 1990 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012193 | Amc Antimicrobial Pin/Wire Sleeve | 2002 | 2 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K900263Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 1990 · Direct predicate · ◆ in the 1990 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- 1 of the 3 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K012193 (Smith & Nephew, Inc., 2002) has gone furthest, with 2 descendants of its own.
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.
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?
Peritoneal Dialysis Catheter with Spi-Argent™ill surface treatment, for the transport of dialysate solution to and from the peritoneal cavity for treatment of renal failure; suitable for CAPD (Continuous Ambulatory Peritoneal Dialysis)
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961392 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961392: Antimicrobial Peritoneal Dialysis Coil Catheter with Spi-Argent II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961392
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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