510(k) · Cleared
ClearedTegaderm Transparent Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Company · KGX Tape And Bandage, Adhesive
Cleared on Jun 2, 1981 after a 22-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Jun 2, 1981
- Review
- 22 days
- Class
- Class I
- Product code
- KGX
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK811291 Tegaderm Transparent Dressing3M Company · 1981
- Descendant · cites it directly · 5 of its ownK961319 EpiviewConvatec, A Division of E.R. Squibb & Sons · 1996
- Descendant · 2 generations on · 4 of its ownK991214 Simplicare Transparent Wound DressingHollister, Inc. · 1999
- Descendant · 3 generations on · 3 of its ownK020781 Wet ChamberKinetic Concepts, Inc. · 2002
- Descendant · 4 generations on · 1 of its ownK060046 DermastreamEnzysurge, Ltd. · 2006
- Descendant · 4 generations on · 0 of its ownK091133 Aplion Topical Care SystemAplion Medical,Llc · 2009
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K961319EpiviewConvatec, A Division of E.R. Squibb & Sons · 1996 · cites it directly5descendants
- K991214Simplicare Transparent Wound DressingHollister, Inc. · 1999 · 2 generations on4descendants
- K020781Wet ChamberKinetic Concepts, Inc. · 2002 · 3 generations on3descendants
- K060046DermastreamEnzysurge, Ltd. · 2006 · 4 generations on1descendant
- K091133Aplion Topical Care SystemAplion Medical,Llc · 2009 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K811291 | Tegaderm Transparent Dressing | 3M Company | 1981 | — |
| +1 | K961319 | Epiview | Convatec, A Division of E.R. Squibb & Sons | 1996 | — |
| +2 | K991214 | Simplicare Transparent Wound Dressing | Hollister, Inc. | 1999 | — |
| +3 | K020781 | Wet Chamber | Kinetic Concepts, Inc. | 2002 | — |
| +4 | K060046 | Dermastream | Enzysurge, Ltd. | 2006 | — |
| +4 | K091133 | Aplion Topical Care System | Aplion Medical,Llc | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KGX? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K961319 (Convatec, A Division of E.R. Squibb & Sons, 1996) has gone furthest, with 5 descendants of its own.
How does its category compare?
All KGX devicesKGX Tape And Bandage, Adhesive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KGX
FDA has decided no KGX device since 2007.
Median 510(k) review, days · KGX
Too few KGX 510(k)s in any year since 2007 to give a median.
Recalls per year · KGX
8in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KGX
317in 2025
MAUDE reports naming product code KGX, 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 | 37 |
| 2008 | 0 | — | 0 | 26 |
| 2009 | 0 | — | 0 | 37 |
| 2010 | 0 | — | 8 | 31 |
| 2011 | 0 | — | 4 | 39 |
| 2012 | 0 | — | 2 | 59 |
| 2013 | 0 | — | 0 | 88 |
| 2014 | 0 | — | 0 | 98 |
| 2015 | 0 | — | 3 | 200 |
| 2016 | 0 | — | 0 | 158 |
| 2017 | 0 | — | 0 | 206 |
| 2018 | 0 | — | 0 | 213 |
| 2019 | 0 | — | 1 | 488 |
| 2020 | 0 | — | 0 | 1,290 |
| 2021 | 0 | — | 0 | 562 |
| 2022 | 0 | — | 0 | 253 |
| 2023 | 0 | — | 0 | 192 |
| 2024 | 0 | — | 0 | 224 |
| 2025 | 0 | — | 8 | 317 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K811291 · printed Nov 6, 2026
Cite this page
510(k) Report. “K811291: Tegaderm Transparent Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K811291
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026