510(k) · Cleared
Recalled · Class II · 2018Kerlix MD Antimicrobial Gauze Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Kendall Company, L.P. · NAD Dressing, Wound, Occlusive
Cleared on Jan 31, 2000 as substantially equivalent to K895993 (Vitaphore Corp., 1990) and 1 other predicate after a 346-day review. Its family tree reaches back 1 generation to 1990. 21 later devices descend from it. It has been recalled 7 times.
- Decided
- Jan 31, 2000
- Review
- 346 days
- Class
- Class I
- Product code
- NAD
- Recalls
- 7
- Predicates
- 2
Its longest line of descent runs back 1 generation to K895993 (1990). 2 ancestors in all. 21 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK895993 Vitapatch Antimicrobial Catheter Securement DeviceVitaphore Corp. · 1990
- This deviceK990530 Kerlix MD Antimicrobial Gauze DressingThe Kendall Company, L.P. · 2000
- Descendant · cites it directly · 7 of its ownK070653 Kendall Kerlix Antimicrobial Super Sponge Dressing for Otc Use…Tyco Healthcare · 2007
- Descendant · cites it directly · 7 of its ownK024054 Xylos Xcell Antimicrobial DressingXylos Corporation · 2003
- Descendant · 2 generations on · 5 of its ownK121522 Polyfit Absorbing Antimicrobial Dressings (Otc)Polyremedy, Inc. · 2012
- Descendant · 3 generations on · 3 of its ownK130857 Prontosan Wound Gel XB.Braun Medical, Inc. · 2013
- Descendant · 2 generations on · 3 of its ownK051647 Fortaderm Antimicrobial Wound DressingOrganogenesis, Inc. · 2005
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K070653Kendall Kerlix Antimicrobial Super Sponge Dressing for Otc Use, Model 6662Tyco Healthcare · 2007 · cites it directly7descendants
- K024054Xylos Xcell Antimicrobial DressingXylos Corporation · 2003 · cites it directly7descendants
- K121522Polyfit Absorbing Antimicrobial Dressings (Otc)Polyremedy, Inc. · 2012 · 2 generations on5descendants
- K130857Prontosan Wound Gel XB.Braun Medical, Inc. · 2013 · 3 generations on3descendants
- K051647Fortaderm Antimicrobial Wound DressingOrganogenesis, Inc. · 2005 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K895993 | Vitapatch Antimicrobial Catheter Securement Device | Vitaphore Corp. | 1990 | — |
| 0 (this device) | K990530 | Kerlix MD Antimicrobial Gauze Dressing | The Kendall Company, L.P. | 2000 | — |
| +1 | K070653 | Kendall Kerlix Antimicrobial Super Sponge Dressing for Otc Use, Model 6662 | Tyco Healthcare | 2007 | — |
| +1 | K024054 | Xylos Xcell Antimicrobial Dressing | Xylos Corporation | 2003 | — |
| +2 | K121522 | Polyfit Absorbing Antimicrobial Dressings (Otc) | Polyremedy, Inc. | 2012 | — |
| +3 | K130857 | Prontosan Wound Gel X | B.Braun Medical, Inc. | 2013 | — |
| +2 | K051647 | Fortaderm Antimicrobial Wound Dressing | Organogenesis, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 NAD? 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 NAD device
- #1 K254246 LT Antibacterial Foam with Silver Dressingscore 13.5 · 6 generations · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K895993 | Vitapatch Antimicrobial Catheter Securement DeviceSummary page 1…sed Kendall Kerlix MD Antimicrobial Gauze Dressing is substantially equivalent in intended use, function and composition to Vitaphore Corporations Vitapatch, 510(k) No. K895993 and Maersk Medical Ltd. Argiaes Antimicrobial Barrier Film Dressing, 510(k) No. K973657. Device Description The proposed Kerli… | 1990 |
| * | K973657 | Arglaes-AB Antimicrobial Barrier Island DressingSummary page 1…ed use, function and composition to Vitaphore Corporations Vitapatch, 510(k) No. K895993 and Maersk Medical Ltd. Argiaes Antimicrobial Barrier Film Dressing, 510(k) No. K973657. Device Description The proposed Kerlix MD Antimicrobial Gauze Dressing is a sterile, single use, wound dressing consisting of… | 1997 |
What descends from it? (21)
See all 215 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 1, 2018 | Class II | Z-0013-2019 | Nonconforming Material/Component | Potential for product sterility breach due to a compromised or pinched seal defect |
| Aug 1, 2018 | Class II | Z-0014-2019 | Nonconforming Material/Component | Potential for product sterility breach due to a compromised or pinched seal defect |
| Aug 1, 2018 | Class II | Z-0017-2019 | Nonconforming Material/Component | Potential for product sterility breach due to a compromised or pinched seal defect |
| Aug 1, 2018 | Class II | Z-0018-2019 | Nonconforming Material/Component | Potential for product sterility breach due to a compromised or pinched seal defect |
| Aug 1, 2018 | Class II | Z-0015-2019 | Nonconforming Material/Component | Potential for product sterility breach due to a compromised or pinched seal defect |
| Aug 1, 2018 | Class II | Z-0016-2019 | Nonconforming Material/Component | Potential for product sterility breach due to a compromised or pinched seal defect |
| Jan 8, 2004 | Not classified | Z-0380-04 | Other | Sterility compromised due to lack of package seal integrity |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K070653 (Tyco Healthcare, 2007) has gone furthest, with 7 descendants of its own.
How does its category compare?
All NAD devicesNAD Dressing, Wound, Occlusive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NAD
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · NAD
Too few NAD 510(k)s in any year since 2007 to give a median.
Recalls per year · NAD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NAD
2,619in 2025
MAUDE reports naming product code NAD, 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 | 1 |
| 2008 | 2 | — | 0 | 8 |
| 2009 | 1 | — | 0 | 9 |
| 2010 | 0 | — | 1 | 30 |
| 2011 | 1 | — | 0 | 9 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 15 |
| 2014 | 0 | — | 1 | 63 |
| 2015 | 0 | — | 0 | 251 |
| 2016 | 0 | — | 0 | 106 |
| 2017 | 0 | — | 0 | 134 |
| 2018 | 0 | — | 6 | 1,029 |
| 2019 | 0 | — | 0 | 588 |
| 2020 | 0 | — | 0 | 5,035 |
| 2021 | 0 | — | 0 | 451 |
| 2022 | 0 | — | 1 | 403 |
| 2023 | 0 | — | 0 | 1,619 |
| 2024 | 0 | — | 0 | 1,804 |
| 2025 | 0 | — | 1 | 2,619 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
KERLIX Antimicrobial Gauze is intended for use as a primary dressing for exuding wounds, first and second degree burns, and surgical wounds, to secure and prevent movement of a primary dressing, and as a wound packing
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/K990530 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990530: Kerlix MD Antimicrobial Gauze Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990530
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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