510(k) · Cleared
ClearedDerma-Aid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Winfield Laboratories, Inc. · NAB Gauze / Sponge,Nonresorbable For External Use
Cleared on Mar 5, 1982 after a 39-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Mar 5, 1982
- Review
- 39 days
- Class
- Class I
- Product code
- NAB
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK820198 Derma-AidWinfield Laboratories, Inc. · 1982
- Descendant · cites it directly · 5 of its ownK973538 N-TerfaceWinfield Laboratories, Inc. · 1997
- Descendant · 2 generations on · 3 of its ownK992221 Acticoat Primary Antimicrobial DressingWestaim Biomedical, Inc. · 2000
- Descendant · 3 generations on · 1 of its ownK011941 Excilon Amd Antimicrobial Sponge Model #7088The Kendall Company · 2001
- Descendant · 4 generations on · 0 of its ownK070685 Kendall Antimicrobial Drain Dressing for Otc Use, Model 6662Tyco Healthcare · 2007
- Descendant · 3 generations on · 0 of its ownK050086 Brennen Medical Silver Glucan Wound DressingBrennen Medical, Inc. · 2006
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K973538N-TerfaceWinfield Laboratories, Inc. · 1997 · cites it directly5descendants
- K992221Acticoat Primary Antimicrobial DressingWestaim Biomedical, Inc. · 2000 · 2 generations on3descendants
- K011941Excilon Amd Antimicrobial Sponge Model #7088The Kendall Company · 2001 · 3 generations on1descendant
- K070685Kendall Antimicrobial Drain Dressing for Otc Use, Model 6662Tyco Healthcare · 2007 · 4 generations on0descendants
- K050086Brennen Medical Silver Glucan Wound DressingBrennen Medical, Inc. · 2006 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K820198 | Derma-Aid | Winfield Laboratories, Inc. | 1982 | — |
| +1 | K973538 | N-Terface | Winfield Laboratories, Inc. | 1997 | — |
| +2 | K992221 | Acticoat Primary Antimicrobial Dressing | Westaim Biomedical, Inc. | 2000 | — |
| +3 | K011941 | Excilon Amd Antimicrobial Sponge Model #7088 | The Kendall Company | 2001 | — |
| +4 | K070685 | Kendall Antimicrobial Drain Dressing for Otc Use, Model 6662 | Tyco Healthcare | 2007 | — |
| +3 | K050086 | Brennen Medical Silver Glucan Wound Dressing | Brennen Medical, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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 NAB? 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? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K973538 | N-Terface | 1997 | 5 |
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, K973538 (Winfield Laboratories, Inc., 1997) has gone furthest, with 5 descendants of its own.
How does its category compare?
All NAB devicesNAB Gauze / Sponge,Nonresorbable For External Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NAB
FDA has decided no NAB device since 2007.
Median 510(k) review, days · NAB
Too few NAB 510(k)s in any year since 2007 to give a median.
Recalls per year · NAB
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NAB
12in 2025
MAUDE reports naming product code NAB, 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 | 6 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 0 | — | 0 | 25 |
| 2017 | 0 | — | 0 | 24 |
| 2018 | 0 | — | 2 | 22 |
| 2019 | 0 | — | 0 | 23 |
| 2020 | 0 | — | 1 | 11 |
| 2021 | 0 | — | 0 | 11 |
| 2022 | 0 | — | 0 | 12 |
| 2023 | 0 | — | 0 | 15 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 12 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K820198 · printed Nov 6, 2026
Cite this page
510(k) Report. “K820198: Derma-Aid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K820198
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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