510(k) · Cleared
Cleared3M Tegaderm Transparent Dressing, 3M Tegaderm Transparent Dressing (First Aid Delivery), 3M Tegaderm HP Transparent Dres
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Healthcare · MGP Dressing, Wound And Burn, Occlusive
Cleared on Nov 12, 1997 after a 90-day review. The FDA summary names its predicate without a number. 21 later devices descend from it.
- Decided
- Nov 12, 1997
- Review
- 90 days
- Class
- Class U
- Product code
- MGP
- Recalls
- None
- Predicates
- 0
21 later devices descend from it, 8 citing it directly.
- This deviceK973036 3M Tegaderm Transparent Dressing, 3M Tegaderm Transparent Dressing…3M Healthcare · 1997
- Descendant · cites it directly · 16 of its ownK063458 3M Tegaderm CHG Dressing3M Company · 2007 · Recalled
- Descendant · cites it directly · 7 of its ownK080620 Modification to 3M Tegaderm CHG Dressing3M Company-3M Health Care · 2008 · Recalled
- Descendant · 2 generations on · 4 of its ownK113836 Benehold CHG Transparent Film Dressing (10X12CM) (8.5X12CM) (6.5X7 CM)Avery Dennison Belgie Bvba · 2012
- Descendant · cites it directly · 3 of its ownK121819 Surgiclear Antimicrobial Clear Silicone Adhesive Dressing with…Covalontechnologies, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK153410 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing3M Company · 2017 · Recalled
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K0634583M Tegaderm CHG Dressing3M Company · 2007 · cites it directly16descendants
- 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 · 2 generations on4descendants
- 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 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973036 | 3M Tegaderm Transparent Dressing, 3M Tegaderm Transparent Dressing (First Aid… | 3M Healthcare | 1997 | — |
| +1 | K063458 | 3M Tegaderm CHG Dressing | 3M Company | 2007 | 1 |
| +1 | K080620 | Modification to 3M Tegaderm CHG Dressing | 3M Company-3M Health Care | 2008 | 1 |
| +2 | K113836 | Benehold CHG Transparent Film Dressing (10X12CM) (8.5X12CM) (6.5X7 CM) | Avery Dennison Belgie Bvba | 2012 | — |
| +1 | K121819 | Surgiclear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine… | Covalontechnologies, Inc. | 2012 | — |
| +2 | K153410 | 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing | 3M Company | 2017 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 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 MGP? 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? (12)
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 |
|---|---|---|---|
| * | — | 3M Tegaderm Transparent Dressing (original frame style) Named without a submission number | |
| * | — | 3M Tegaderm Transparent Dressing (easy application frame style) Named without a submission number | |
| * | — | 3M Tegaderm Transparent Dressing (First Aid Delivery) Named without a submission number | |
| * | — | 3M Tegaderm HP Transparent Dressing Named without a submission number | |
| * | — | 3M Tegaderm Transparent I.V. Dressing Named without a submission number | |
| * | — | Op-Site Transparent Permeable Membrane Named without a submission number | |
| * | — | OpSite I.V. 3000 Named without a submission number | |
| * | — | Bioclusive Transparent Dressing Named without a submission number | |
| * | — | Transeal Transparent Dressing Named without a submission number | |
| * | — | Conmed Veni-Gard Dressing Named without a submission number | |
| * | — | Pro-Clude Transparent Wound Dressing Named without a submission number | |
| * | — | Polyskin M.R. Moisture Responsive Transparent Dressing Named without a submission number |
What descends from it? (21)
See all 218 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063458 | 3M Tegaderm CHG Dressing | 2007 | 16 |
| K080620 | Modification to 3M Tegaderm CHG Dressing | 2008 | 7 |
| K121819 | Surgiclear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and Silver | 2012 | 3 |
| K060046 | Dermastream | 2006 | 1 |
| K140389 | Chloraderm Antimicrobial Transparent Thin Film Dressing, 2 3/8 X 2 3/4, 4 X 4 3/4 | 2014 | 0 |
| K130553 | Absoclear | 2013 | 0 |
| K112549 | IV Clear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and Silver | 2012 | 0 |
| K043063 | Oxyband Wound Dressing | 2005 | 0 |
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, K063458 (3M Company, 2007) has gone furthest, with 16 descendants of its own.
How does its category compare?
All MGP devicesMGP Dressing, Wound And Burn, Occlusive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MGP
FDA has decided no MGP device since 2007.
Median 510(k) review, days · MGP
Too few MGP 510(k)s in any year since 2007 to give a median.
Recalls per year · MGP
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MGP
8in 2024
MAUDE reports naming product code MGP, 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 1 | 4 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 7 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 52 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
3M Tegaderm Transparent Dressings can be used to cover and protect catheter sites and wounds, to create a moist enviroment for wound healing, as a secondary dressing, as a protective cover over at risk skin, to secure devices to the skin and as a protective eye covering. It can also be used to create a moist wound environment to facxlltate autolytic debridement. Common applications include: IV catheters, other mtravascular catheters and percutaneous…
Read the full statement (126 words)
3M Tegaderm Transparent Dressings can be used to cover and protect catheter sites and wounds, to create a moist enviroment for wound healing, as a secondary dressing, as a protective cover over at risk skin, to secure devices to the skin and as a protective eye covering. It can also be used to create a moist wound environment to facxlltate autolytic debridement. Common applications include: IV catheters, other mtravascular catheters and percutaneous devices, clean closed surgical incisions, sluu graft donor sites, Stage I or II pressure ulcers, superficial wounds such as Iabrasums, skin tears, and blister, first and second degree burns, chafed skin or skinicontinuously exposed to moisture, secondary dressing over gauze, alginates or hydrogels, protective eye covering during surgery or for patients with corneal abrasions.
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/K973036 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973036: 3M Tegaderm Transparent Dressing, 3M Tegaderm Transparent Dressing (First Aid Delivery), 3M Tegaderm HP Transparent Dres.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973036
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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