510(k) · Cleared
Cleared3M Tegasorb Thin Hydrocolloid Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Company · KMF Bandage, Liquid
Cleared on Oct 26, 1998 as substantially equivalent to K924280 (3M Health Care, Ltd., 1993) after a 70-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.
- Decided
- Oct 26, 1998
- Review
- 70 days
- Class
- Class I
- Product code
- KMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K924280 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK924280 3M Tegasorb Thin Hydrocolloid Dressing3M Health Care, Ltd. · 1993
- This deviceK982892 3M Tegasorb Thin Hydrocolloid Dressing3M Company · 1998
- Descendant · cites it directly · 0 of its ownK082208 Doctors Choice Slow Healing Bandage with Spray on RemoverScivolutions, Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K082208Doctors Choice Slow Healing Bandage with Spray on RemoverScivolutions, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924280 | 3M Tegasorb Thin Hydrocolloid Dressing | 3M Health Care, Ltd. | 1993 | — |
| 0 (this device) | K982892 | 3M Tegasorb Thin Hydrocolloid Dressing | 3M Company | 1998 | — |
| +1 | K082208 | Doctors Choice Slow Healing Bandage with Spray on Remover | Scivolutions, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 KMF? 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 KMF device
- #1 K241916 TearRepair Liquid Skin Protectantscore 8.1 · 1 generation · no Class I recall
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K924280 | 3M Tegasorb Thin Hydrocolloid DressingSummary page 1…ul, Minnesota 55144-1000 (651) 733-7948 August 13, 1998 3M Tegasorb™ THIN Hydrocolloid Dressing Wound Dressing Wound Dressing 3M Tegasorb™ Ulcer Dressing (see also, K924280, May 12, 1993, for competitive comparable products). [3M Tegasorb™ and] 3M Tegasorb™ Thin Hydrocolloid Dressings are sterile wou… | 1993 |
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 |
|---|---|---|---|
| K082208 | Doctors Choice Slow Healing Bandage with Spray on Remover | 2008 | 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?
- Its one ancestor has no recall.
- Of its descendants, K082208 (Scivolutions, Inc., 2008) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KMF devicesKMF Bandage, Liquid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KMF
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · KMF
213in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KMF
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KMF
12in 2025
MAUDE reports naming product code KMF, 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 | 2 | — | 1 | 6 |
| 2008 | 3 | 35 | 0 | 2 |
| 2009 | 3 | 213 | 0 | 6 |
| 2010 | 1 | — | 0 | 7 |
| 2011 | 0 | — | 1 | 16 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 34 |
| 2014 | 2 | — | 0 | 24 |
| 2015 | 0 | — | 0 | 13 |
| 2016 | 2 | — | 0 | 18 |
| 2017 | 0 | — | 0 | 16 |
| 2018 | 1 | — | 0 | 10 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 1 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 12 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The following conditions are considered appropriate for OTC use by the lay person:
Superficial wounds such as cuts, lacerations, or abrasions
First-degree burns
Skin needing protection from friction or sheer
The following conditions are considered appropriate for OTC use under the supervision of a health care professional:
Partial thickness dermal ulcers
Leg ulcers
Second-degree burns
Donor sites
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/K982892 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982892: 3M Tegasorb Thin Hydrocolloid Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982892
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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