510(k) · Cleared
ClearedVitapatch Antimicrobial Catheter Securement Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vitaphore Corp. · KMK Device, Intravascular Catheter Securement
Cleared on Jan 11, 1990 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 22 later devices descend from it.
- Decided
- Jan 11, 1990
- Review
- 90 days
- Class
- Class I
- Product code
- KMK
- Recalls
- None
- Predicates
- 0
22 later devices descend from it, 1 citing it directly.
- This deviceK895993 Vitapatch Antimicrobial Catheter Securement DeviceVitaphore Corp. · 1990
- Descendant · cites it directly · 21 of its ownK990530 Kerlix MD Antimicrobial Gauze DressingThe Kendall Company, L.P. · 2000 · Recalled
- Descendant · 2 generations on · 7 of its ownK070653 Kendall Kerlix Antimicrobial Super Sponge Dressing for Otc Use…Tyco Healthcare · 2007
- Descendant · 2 generations on · 7 of its ownK024054 Xylos Xcell Antimicrobial DressingXylos Corporation · 2003
- Descendant · 3 generations on · 5 of its ownK121522 Polyfit Absorbing Antimicrobial Dressings (Otc)Polyremedy, Inc. · 2012
- Descendant · 4 generations on · 3 of its ownK130857 Prontosan Wound Gel XB.Braun Medical, Inc. · 2013
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K990530Kerlix MD Antimicrobial Gauze DressingThe Kendall Company, L.P. · 2000 · cites it directly21descendants
- K070653Kendall Kerlix Antimicrobial Super Sponge Dressing for Otc Use, Model 6662Tyco Healthcare · 2007 · 2 generations on7descendants
- K024054Xylos Xcell Antimicrobial DressingXylos Corporation · 2003 · 2 generations on7descendants
- K121522Polyfit Absorbing Antimicrobial Dressings (Otc)Polyremedy, Inc. · 2012 · 3 generations on5descendants
- K130857Prontosan Wound Gel XB.Braun Medical, Inc. · 2013 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K895993 | Vitapatch Antimicrobial Catheter Securement Device | Vitaphore Corp. | 1990 | — |
| +1 | K990530 | Kerlix MD Antimicrobial Gauze Dressing | The Kendall Company, L.P. | 2000 | 7 |
| +2 | K070653 | Kendall Kerlix Antimicrobial Super Sponge Dressing for Otc Use, Model 6662 | Tyco Healthcare | 2007 | — |
| +2 | K024054 | Xylos Xcell Antimicrobial Dressing | Xylos Corporation | 2003 | — |
| +3 | K121522 | Polyfit Absorbing Antimicrobial Dressings (Otc) | Polyremedy, Inc. | 2012 | — |
| +4 | K130857 | Prontosan Wound Gel X | B.Braun Medical, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2020 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2026 | 2 | 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.
Planning a device in KMK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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? (22)
See all 221 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990530 | Kerlix MD Antimicrobial Gauze Dressing | 2000 | 21 |
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?
- Of its descendants, K990530 (The Kendall Company, L.P., 2000) has gone furthest, with 21 descendants of its own.
How does its category compare?
All KMK devicesKMK Device, Intravascular Catheter Securement: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KMK
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · KMK
Too few KMK 510(k)s in any year since 2007 to give a median.
Recalls per year · KMK
2in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KMK
75in 2025
MAUDE reports naming product code KMK, 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 | — | 3 | 1 |
| 2008 | 0 | — | 0 | 7 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 18 |
| 2015 | 0 | — | 0 | 41 |
| 2016 | 0 | — | 2 | 19 |
| 2017 | 0 | — | 0 | 45 |
| 2018 | 0 | — | 0 | 40 |
| 2019 | 1 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 14 |
| 2021 | 0 | — | 0 | 33 |
| 2022 | 0 | — | 0 | 103 |
| 2023 | 0 | — | 0 | 138 |
| 2024 | 0 | — | 0 | 104 |
| 2025 | 0 | — | 0 | 75 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K895993 · printed Nov 6, 2026
Cite this page
510(k) Report. “K895993: Vitapatch Antimicrobial Catheter Securement Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K895993
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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