510(k) · Cleared
ClearedN-Terface
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Winfield Laboratories, Inc. · MGP Dressing, Wound And Burn, Occlusive
Cleared on Dec 16, 1997 as substantially equivalent to K820198 (Winfield Laboratories, Inc., 1982) after an 89-day review. Its family tree reaches back 1 generation to 1982. 5 later devices descend from it.
- Decided
- Dec 16, 1997
- Review
- 89 days
- Class
- Class U
- Product code
- MGP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K820198 (1982). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK820198 Derma-AidWinfield Laboratories, Inc. · 1982
- This deviceK973538 N-TerfaceWinfield Laboratories, Inc. · 1997
- Descendant · cites it directly · 3 of its ownK992221 Acticoat Primary Antimicrobial DressingWestaim Biomedical, Inc. · 2000
- Descendant · 2 generations on · 1 of its ownK011941 Excilon Amd Antimicrobial Sponge Model #7088The Kendall Company · 2001
- Descendant · 3 generations on · 0 of its ownK070685 Kendall Antimicrobial Drain Dressing for Otc Use, Model 6662Tyco Healthcare · 2007
- Descendant · 2 generations on · 0 of its ownK050086 Brennen Medical Silver Glucan Wound DressingBrennen Medical, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK981713 Cicanet Wound Contact Layer Dressing - 2 X 3 in. Model 59100600…Smith & Nephew, Inc. · 1998
Most influential descendants
Showing 5 of 5 · See all- K992221Acticoat Primary Antimicrobial DressingWestaim Biomedical, Inc. · 2000 · cites it directly3descendants
- K011941Excilon Amd Antimicrobial Sponge Model #7088The Kendall Company · 2001 · 2 generations on1descendant
- K070685Kendall Antimicrobial Drain Dressing for Otc Use, Model 6662Tyco Healthcare · 2007 · 3 generations on0descendants
- K050086Brennen Medical Silver Glucan Wound DressingBrennen Medical, Inc. · 2006 · 2 generations on0descendants
- K981713Cicanet Wound Contact Layer Dressing - 2 X 3 in. Model 59100600, Cicanet Wound Contact…Smith & Nephew, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K820198 | Derma-Aid | Winfield Laboratories, Inc. | 1982 | — |
| 0 (this device) | K973538 | N-Terface | Winfield Laboratories, Inc. | 1997 | — |
| +1 | K992221 | Acticoat Primary Antimicrobial Dressing | Westaim Biomedical, Inc. | 2000 | — |
| +2 | K011941 | Excilon Amd Antimicrobial Sponge Model #7088 | The Kendall Company | 2001 | — |
| +3 | K070685 | Kendall Antimicrobial Drain Dressing for Otc Use, Model 6662 | Tyco Healthcare | 2007 | — |
| +2 | K050086 | Brennen Medical Silver Glucan Wound Dressing | Brennen Medical, Inc. | 2006 | — |
| +1 | K981713 | Cicanet Wound Contact Layer Dressing - 2 X 3 in. Model 59100600, Cicanet Wound… | Smith & Nephew, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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? (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 |
|---|---|---|---|
| * | K820198 | Derma-AidSummary page 1…been classified. Predicate Device: N-TERFACE?® Interpositional Surfacing Material manufactured by Winfield Laboratories, Inc., 10488 Brockwood Road, Dallas, TX 75238. (K820198). Description of Device: N-TERFACE?® Interpositional Surfacing Material is an extruded, non-woven, high density polyethylene sh… | 1982 |
What descends from it? (5)
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?
- Its one ancestor has no recall.
- Of its descendants, K992221 (Westaim Biomedical, Inc., 2000) has gone furthest, with 3 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?
N-TERFACE® Interpositional Surfacing Material is indicated for use as a wound contact layer for partial thickness burns as a result of the procedure of laser skin resurfacing.
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/K973538 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973538: N-Terface.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973538
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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