510(k) · Cleared
Recalled · 2007Comfeel Seasorb Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coloplast Corp. · KMF Bandage, Liquid
Cleared on Dec 30, 1998 as substantially equivalent to K953497 (Coloplast A/S, 1995) after an 83-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it. It has been recalled once.
- Decided
- Dec 30, 1998
- Review
- 83 days
- Class
- Class I
- Product code
- KMF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K953497 (1995). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK953497 Comfeel:Alginate DressingColoplast A/S · 1995
- This deviceK983519 Comfeel Seasorb DressingColoplast Corp. · 1998
- Descendant · cites it directly · 0 of its ownK102942 Coreleader Algiplaster Model AP 050501Coreleader Biotech Co., Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK102943 Coreleader Algi-Fiber Wound Dressing Model Adw 05050Coreleader Biotech Co., Ltd. · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953497 | Comfeel:Alginate Dressing | Coloplast A/S | 1995 | — |
| 0 (this device) | K983519 | Comfeel Seasorb Dressing | Coloplast Corp. | 1998 | — |
| +1 | K102942 | Coreleader Algiplaster Model AP 050501 | Coreleader Biotech Co., Ltd. | 2011 | — |
| +1 | K102943 | Coreleader Algi-Fiber Wound Dressing Model Adw 05050 | Coreleader Biotech Co., Ltd. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 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 |
|---|---|---|---|
| * | K953497 | Comfeel:Alginate DressingSummary page 1…revised Comfeel® Seasorb Dressing is aquivalent to ihe original Comfeel® Alginate (Seasorb) Dressing. manufactured by Coloplast A/S and approved for market under 510(k) K953497, but with minor alterations. 5. Intended Use The revised Comfeel® Seasorb Dressing is indicated (under the guidance of a health… | 1995 |
What descends from it? (2)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 14, 2007 | Not classified | Z-0710-2007 | Other | Coloplast Corp. is recalling Sea-Clens brands Sea-Clens wound cleaner which were found to have some particulates (foreign materials). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K102942 (Coreleader Biotech Co., Ltd., 2011) 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 Comfeel® Seasorb Dressing is indicated for use (under the guidance of a health care professional) in management of moderate to heavily exudating wounds, partial and full thickness wounds, including leg ulcers and pressure sores.
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/K983519 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983519: Comfeel Seasorb Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983519
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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