510(k) · Cleared
Recalled · Class II · 20243M Tegaderm CHG Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Company · FRO Dressing, Wound, Drug
Cleared on Apr 5, 2007 as substantially equivalent to K973036 (3M Healthcare, 1997) and 1 other predicate after a 141-day review. Its family tree reaches back 2 generations to 1991. 16 later devices descend from it. It has been recalled once.
- Decided
- Apr 5, 2007
- Review
- 141 days
- Class
- Class U
- Product code
- FRO
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K895920 (1991). 3 ancestors in all. 16 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK895920 Vitapatch Pin Protection Device for PercutaneousVitaphore Corp. · 1991
- 1 generation backK003229 Biopatch Antimicrobial DressingIntegra Lifesciences Corp. · 2001
- This deviceK063458 3M Tegaderm CHG Dressing3M Company · 2007
- Descendant · cites it directly · 7 of its ownK080620 Modification to 3M Tegaderm CHG Dressing3M Company-3M Health Care · 2008 · Recalled
- Descendant · cites it directly · 4 of its ownK113836 Benehold CHG Transparent Film Dressing (10X12CM) (8.5X12CM) (6.5X7 CM)Avery Dennison Belgie Bvba · 2012
- Descendant · 2 generations on · 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 · 3 generations on · 1 of its ownK163529 ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op…Avery Dennison Corporation · 2017
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K080620Modification to 3M Tegaderm CHG Dressing3M Company-3M Health Care · 2008 · cites it directly7descendants
- K113836Benehold CHG Transparent Film Dressing (10X12CM) (8.5X12CM) (6.5X7 CM)Avery Dennison Belgie Bvba · 2012 · cites it directly4descendants
- K121819Surgiclear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and SilverCovalontechnologies, Inc. · 2012 · 2 generations on3descendants
- 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 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K895920 | Vitapatch Pin Protection Device for Percutaneous | Vitaphore Corp. | 1991 | — |
| −1 | K003229 | Biopatch Antimicrobial Dressing | Integra Lifesciences Corp. | 2001 | — |
| 0 (this device) | K063458 | 3M Tegaderm CHG Dressing | 3M Company | 2007 | — |
| +1 | K080620 | Modification to 3M Tegaderm CHG Dressing | 3M Company-3M Health Care | 2008 | 1 |
| +1 | K113836 | Benehold CHG Transparent Film Dressing (10X12CM) (8.5X12CM) (6.5X7 CM) | Avery Dennison Belgie Bvba | 2012 | — |
| +2 | 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 |
| +3 | K163529 | ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing… | Avery Dennison Corporation | 2017 | — |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 5 | 0 |
| 2020 | 1 | 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? (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 |
|---|---|---|---|
| * | K973036 | 3M Tegaderm Transparent Dressing, 3M Tegaderm Transparent Dressing (First Aid Delivery)…Summary page 1…tion Name: Dressing, Unclassified Performance Standards: None 3. Predicate Devices: * T Transparent Dressings (l6xx series) (K973036) 3MTm TegaderMm * Integra LifeSciences BIOPATCH Antimicrobial Dressing (K003229) 4. Descr… | 1997 |
| * | K003229 | Biopatch Antimicrobial DressingSummary page 1…vices: * T Transparent Dressings (l6xx series) (K973036) 3MTm TegaderMm * Integra LifeSciences BIOPATCH Antimicrobial Dressing (K003229) 4. Description of Device: 3MTM Tegaderm TM CHG Dressing, Chlorhexidine Gluconate Securement Dressing, is use… | 2001 |
What descends from it? (16)
See all 166 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080620 | Modification to 3M Tegaderm CHG Dressing | 2008 | 7 |
| K113836 | Benehold CHG Transparent Film Dressing (10X12CM) (8.5X12CM) (6.5X7 CM) | 2012 | 4 |
| K153410 | 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing | 2017 | 1 |
| K123679 | 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Port Dressing | 2013 | 1 |
| K171908 | 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing | 2017 | 0 |
| K103106 | Chlorashield TM Antimicrobial Dressing | 2011 | 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 16 years and passes through 3 companies; a new generation was cleared every 10.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K080620 (3M Company-3M Health Care, 2008) has gone furthest, with 7 descendants of its own.
- 7 other devices also cite its predicate K973036.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 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/K063458 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063458: 3M Tegaderm CHG Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063458
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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