510(k) · Cleared
Recalled · Class II · 2024Modification to 3M Tegaderm CHG Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Company-3M Health Care · FRO Dressing, Wound, Drug
Cleared on May 19, 2008 as substantially equivalent to K063458 (3M Company, 2007) and 3 other predicates after a 76-day review. Its family tree reaches back 3 generations to 1991. 7 later devices descend from it. It has been recalled once.
- Decided
- May 19, 2008
- Review
- 76 days
- Class
- Class U
- Product code
- FRO
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 3 generations to K895920 (1991). 6 ancestors in all, the oldest K895207 (1989). 7 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK895920 Vitapatch Pin Protection Device for PercutaneousVitaphore Corp. · 1991
- 2 generations backK003229 Biopatch Antimicrobial DressingIntegra Lifesciences Corp. · 2001
- 1 generation backK063458 3M Tegaderm CHG Dressing3M Company · 2007 · Recalled
- This deviceK080620 Modification to 3M Tegaderm CHG Dressing3M Company-3M Health Care · 2008
- Descendant · cites it directly · 3 of its ownK121819 Surgiclear Antimicrobial Clear Silicone Adhesive Dressing with…Covalontechnologies, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK153410 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing3M Company · 2017 · Recalled
- Descendant · 2 generations on · 1 of its ownK163529 ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op…Avery Dennison Corporation · 2017
- Descendant · 3 generations on · 0 of its ownK251866 Tegaderm Post-Op Transparent Antimicrobial DressingSolventum US, LLC · 2025
- Descendant · cites it directly · 0 of its ownK171908 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing3M Company · 2017 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K121819Surgiclear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and SilverCovalontechnologies, Inc. · 2012 · cites it directly3descendants
- K1534103M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing3M Company · 2017 · cites it directly1descendant
- K163529ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG…Avery Dennison Corporation · 2017 · 2 generations on1descendant
- K251866Tegaderm Post-Op Transparent Antimicrobial DressingSolventum US, LLC · 2025 · 3 generations on0descendants
- 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 |
|---|---|---|---|---|---|
| −3 | K895920 | Vitapatch Pin Protection Device for Percutaneous | Vitaphore Corp. | 1991 | — |
| −2 | K003229 | Biopatch Antimicrobial Dressing | Integra Lifesciences Corp. | 2001 | — |
| −1 | K063458 | 3M Tegaderm CHG Dressing | 3M Company | 2007 | 1 |
| 0 (this device) | K080620 | Modification to 3M Tegaderm CHG Dressing | 3M Company-3M Health Care | 2008 | — |
| +1 | K121819 | Surgiclear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine… | Covalontechnologies, Inc. | 2012 | — |
| +1 | K153410 | 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing | 3M Company | 2017 | 1 |
| +2 | K163529 | ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing… | Avery Dennison Corporation | 2017 | — |
| +3 | K251866 | Tegaderm Post-Op Transparent Antimicrobial Dressing | Solventum US, LLC | 2025 | — |
| +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 |
|---|---|---|
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2017 | 3 | 0 |
| 2025 | 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 FRO? 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 FRO device
- #1 K261023 Microdacyn Wound Irrigation Solutionscore 15.5 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 1…ion Name: Antimicrobial Dressing, Unclassified Performance Standards: None 3. Predicate Devices: * 3MTM Tegaderm TM CHG Dressings (K063458, cleared April 5, 2007) * Bioclusive Transparent Film Dressing (K895207, cleared September 28, 1989) · Opsite IV 30… | 2007 |
| * | K895207 | Bioclusive* Transparent Film Dressing - New ClaimSummary page 1…andards: None 3. Predicate Devices: * 3MTM Tegaderm TM CHG Dressings (K063458, cleared April 5, 2007) * Bioclusive Transparent Film Dressing (K895207, cleared September 28, 1989) · Opsite IV 3000 (K895353, cleared December 14, 1989) * TegadermTM Transparent Film Dr… | 1989 |
| * | K895353 | Opsite I.V. 3000Summary page 1…M Tegaderm TM CHG Dressings (K063458, cleared April 5, 2007) * Bioclusive Transparent Film Dressing (K895207, cleared September 28, 1989) · Opsite IV 3000 (K895353, cleared December 14, 1989) * TegadermTM Transparent Film Dressings (K973036, cleared November 12, 1997) · SorbaVie… | 1989 |
| * | K973036 | 3M Tegaderm Transparent Dressing, 3M Tegaderm Transparent Dressing (First Aid Delivery)…Summary page 1…nsparent Film Dressing (K895207, cleared September 28, 1989) · Opsite IV 3000 (K895353, cleared December 14, 1989) * TegadermTM Transparent Film Dressings (K973036, cleared November 12, 1997) · SorbaView® Ultimate Window Dressing * SorbaView® 2000 4. Description of Device… | 1997 |
| * | — | SorbaView Ultimate Window Dressing Named without a submission number | |
| * | — | SorbaView 2000 Named without a submission number |
What descends from it? (7)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121819 | Surgiclear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and Silver | 2012 | 3 |
| K153410 | 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing | 2017 | 1 |
| K171908 | 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing | 2017 | 0 |
| K112549 | IV Clear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and Silver | 2012 | 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 17 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K121819 (Covalontechnologies, Inc., 2012) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K063458.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · FRO
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRO
176in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRO
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · FRO
192in 2025
MAUDE reports naming product code FRO, 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 | 29 | 187 | 4 | 55 |
| 2008 | 26 | 130 | 1 | 30 |
| 2009 | 31 | 136 | 1 | 45 |
| 2010 | 31 | 146 | 0 | 122 |
| 2011 | 27 | 177 | 4 | 42 |
| 2012 | 24 | 96 | 0 | 65 |
| 2013 | 19 | 194 | 1 | 139 |
| 2014 | 22 | 214 | 1 | 269 |
| 2015 | 28 | 249 | 2 | 297 |
| 2016 | 28 | 222 | 3 | 147 |
| 2017 | 23 | 147 | 1 | 149 |
| 2018 | 20 | 206 | 0 | 128 |
| 2019 | 16 | 270 | 1 | 136 |
| 2020 | 12 | 226 | 0 | 139 |
| 2021 | 8 | 275 | 6 | 183 |
| 2022 | 9 | 332 | 2 | 176 |
| 2023 | 18 | 283 | 2 (2) | 198 |
| 2024 | 24 | 263 | 2 | 232 |
| 2025 | 11 | 176 | 0 | 192 |
| 2026 | 17 | 254 | 2 | — |
What is it indicated for?
3M Tegaderm CHG Dressings (Chlorhexidine Gluconate I.V. Securement Dressing), can be used to cover and protect catheter sites and to secure devices to skin. Common applications include IV catheters, other intravascular catheter and percutaneous devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080620 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080620: Modification to 3M Tegaderm CHG Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080620
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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