510(k) · Cleared
ClearedVitaguard Percutaneous Infection Control Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vitaphore Corp. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Aug 27, 1986 after a 124-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 13 devices in its family, counting itself, have a Class I recall. 12 later devices descend from it.
- Decided
- Aug 27, 1986
- Review
- 124 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 2 citing it directly. 2 of the 13 devices in this family, counting this one, have a Class I recall.
- This deviceK861563 Vitaguard Percutaneous Infection Control KitVitaphore Corp. · 1986
- Descendant · cites it directly · 7 of its ownK060972 Kedall 14.5 FR Chronic Hemodialysis Catheter W/Silver Impregnated…Kendall · 2006 · Recalled
- Descendant · 2 generations on · 6 of its ownK062671 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating and…Kendall · 2006 · Recalled
- Descendant · 2 generations on · 5 of its ownK112477 Palindrome H, SI, Hsi Chronic CatheterCovidien · 2011 · Recalled (Class I)
- Descendant · 3 generations on · 4 of its ownK123196 Palindrome Precision H Chronic Catheter, Palindrome Precision SI…Covidien · 2013 · Recalled (Class I)
- Descendant · 4 generations on · 3 of its ownK140884 Symetrex Long Term Hemodialysis CatheterPhase One Medical · 2014
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 12 · See all- K060972Kedall 14.5 FR Chronic Hemodialysis Catheter W/Silver Impregnated Sleeve (Palindrome Ruby)Kendall · 2006 · cites it directly7descendants
- K06267114.5 FR Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve…Kendall · 2006 · 2 generations on6descendants
- K112477Palindrome H, SI, Hsi Chronic CatheterCovidien · 2011 · 2 generations on5descendants
- K123196Palindrome Precision H Chronic Catheter, Palindrome Precision SI Chronic Catheter…Covidien · 2013 · 3 generations on4descendants
- K140884Symetrex Long Term Hemodialysis CatheterPhase One Medical · 2014 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K861563 | Vitaguard Percutaneous Infection Control Kit | Vitaphore Corp. | 1986 | — |
| +1 | K060972 | Kedall 14.5 FR Chronic Hemodialysis Catheter W/Silver Impregnated Sleeve… | Kendall | 2006 | 38 |
| +2 | K062671 | 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating and Silver… | Kendall | 2006 | 24 |
| +2 | K112477 | Palindrome H, SI, Hsi Chronic Catheter | Covidien | 2011 | Class I |
| +3 | K123196 | Palindrome Precision H Chronic Catheter, Palindrome Precision SI Chronic… | Covidien | 2013 | Class I |
| +4 | K140884 | Symetrex Long Term Hemodialysis Catheter | Phase One Medical | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2006 | 3 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 1 |
| 2013 | 1 | 1 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have 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 LJS device
- #1 K241910 Neonav ECG Tip Location Systemscore 18.0 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (12)
See all 122 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 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.
- K112477Palindrome H, SI, Hsi Chronic CatheterCovidien · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 13 Class I recalls
- K123196Palindrome Precision H Chronic Catheter, Palindrome Precision SI Chronic Catheter, Palindrome Precision Hsi…Covidien · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- Of its descendants, K060972 (Kendall, 2006) has gone furthest, with 7 descendants of its own.
How does its category compare?
All LJS devicesLJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LJS
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LJS
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LJS
5in 2023
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · LJS
4,372in 2025
MAUDE reports naming product code LJS, 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 | 14 | 92 | 0 | 392 |
| 2008 | 4 | 97 | 1 | 369 |
| 2009 | 16 | 70 | 1 | 379 |
| 2010 | 9 | 114 | 12 | 495 |
| 2011 | 6 | 55 | 4 | 696 |
| 2012 | 14 | 77 | 40 | 564 |
| 2013 | 14 | 31 | 0 | 680 |
| 2014 | 8 | 47 | 15 | 842 |
| 2015 | 7 | 71 | 2 | 1,306 |
| 2016 | 9 | 128 | 18 | 1,123 |
| 2017 | 7 | 101 | 9 | 2,100 |
| 2018 | 10 | 148 | 3 | 2,324 |
| 2019 | 0 | — | 0 | 2,052 |
| 2020 | 2 | — | 0 | 2,539 |
| 2021 | 3 | 284 | 1 | 3,084 |
| 2022 | 3 | 177 | 0 | 3,256 |
| 2023 | 4 | 47 | 5 (2) | 2,799 |
| 2024 | 1 | — | 0 | 4,243 |
| 2025 | 8 | 171 | 0 | 4,372 |
| 2026 | 2 | — | 8 (1) | — |
https://510kreport.com/device/K861563 · printed Nov 5, 2026
Cite this page
510(k) Report. “K861563: Vitaguard Percutaneous Infection Control Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K861563
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026