510(k) · Cleared
Recalled · Class II · 20243M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Company · SEL Securement Wound Dressing For Reduction Of Infection
Cleared on May 15, 2017 as substantially equivalent to K063458 (3M Company, 2007) and 2 other predicates after a 537-day review. Its family tree reaches back 4 generations to 1991. 1 later device descends from it. It has been recalled once.
- Decided
- May 15, 2017
- Review
- 537 days
- Class
- Class U
- Product code
- SEL
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 4 generations to K895920 (1991). 7 ancestors in all, the oldest K895207 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK895920 Vitapatch Pin Protection Device for PercutaneousVitaphore Corp. · 1991
- 3 generations backK003229 Biopatch Antimicrobial DressingIntegra Lifesciences Corp. · 2001
- 2 generations backK063458 3M Tegaderm CHG Dressing3M Company · 2007 · Recalled
- 1 generation backK080620 Modification to 3M Tegaderm CHG Dressing3M Company-3M Health Care · 2008 · Recalled
- This deviceK153410 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing3M Company · 2017
- Descendant · cites it directly · 0 of its ownK171908 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing3M Company · 2017 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K1719083M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing3M Company · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K895920 | Vitapatch Pin Protection Device for Percutaneous | Vitaphore Corp. | 1991 | — |
| −3 | K003229 | Biopatch Antimicrobial Dressing | Integra Lifesciences Corp. | 2001 | — |
| −2 | K063458 | 3M Tegaderm CHG Dressing | 3M Company | 2007 | 1 |
| −1 | K080620 | Modification to 3M Tegaderm CHG Dressing | 3M Company-3M Health Care | 2008 | 1 |
| 0 (this device) | K153410 | 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing | 3M Company | 2017 | — |
| +1 | K171908 | 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing | 3M Company | 2017 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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.
Planning a device in SEL? 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? (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 |
|---|---|---|---|
| * | K063458 | 3M Tegaderm CHG DressingSummary page 5…510(k) Premarket Notification - Traditional III. PREDICATE DEVICE(S) 3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing (K063458, K080620) BIOPATCH Antimicrobial Dressing (K003229) No reference devices are used in this submission. IV. DEVIC… | 2007 |
| * | K080620 | Modification to 3M Tegaderm CHG DressingSummary page 5…510(k) Premarket Notification - Traditional III. PREDICATE DEVICE(S) 3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing (K063458, K080620) BIOPATCH Antimicrobial Dressing (K003229) No reference devices are used in this submission. IV. DEVICE DESCRIP… | 2008 |
| * | K003229 | Biopatch Antimicrobial DressingSummary page 5…itional III. PREDICATE DEVICE(S) 3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing (K063458, K080620) BIOPATCH Antimicrobial Dressing (K003229) No reference devices are used in this submission. IV. DEVICE DESCRIPTION 3M™ Tegaderm™ CHG Chlorhexidine Gluco… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171908 | 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing | 2017 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 14, 2024 | Class II | Z-0038-2025 | Under Investigation by firm | Contamination with foreign substance matter |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 4 companies; a new generation was cleared every 9.0 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K171908 (3M Company, 2017) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K063458.
How does its category compare?
All SEL devicesSEL Securement Wound Dressing For Reduction Of Infection: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · SEL
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · SEL
Too few SEL 510(k)s in any year since 2007 to give a median.
Recalls per year · SEL
No recall names SEL since 2007.
Adverse event reports per year · SEL
No MAUDE report names SEL since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing can be used to cover and protect catheter sites and to secure devices to skin. Common applications include securing and covering I.V. catheters, other intravascular catheters and percutaneous devices.
Tegaderm™ CHG I.V. Securement Dressing is intended to reduce vascular catheter colonization and catheter-related bloodstream infections (CRBSI) in patients with central venous or arterial catheters.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153410 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153410: 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153410
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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