510(k) · Cleared
ClearedNeufinish Resurfacing Cream
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neutrogena Corp. · MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Cleared on Oct 21, 1998 as substantially equivalent to K932263 (Smith & Nephew United, Inc., 1993) and 1 other predicate after an 89-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Oct 21, 1998
- Review
- 89 days
- Class
- Class U
- Product code
- MGQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K864124 (1986). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK864124 Spand-Gel Granulated GelMedi-Tech Intl. Corp. · 1986
- This deviceK982577 Neufinish Resurfacing CreamNeutrogena Corp. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K864124 | Spand-Gel Granulated Gel | Medi-Tech Intl. Corp. | 1986 | — |
| 0 (this device) | K982577 | Neufinish Resurfacing Cream | Neutrogena Corp. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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 MGQ? 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? (2)
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 |
|---|---|---|---|
| * | K932263 | Solosite Dermal Wound GelSummary page 2…urn, hydrogel (Surgery 79 MGQ) Common / usual name Hydrogel dressing Proprietary name Neutrogena MD™ Cream with Glycerin « SoloSite Dermal Wound Gel (Smith & Nephew, K932263) + Spand-Gel Wound Gel (K864124, Medi-Tech International) Neutrogena MD™ Cream with Glycerin is a hydrogel wound dressing compos… | 1993 |
| * | K864124 | Spand-Gel Granulated GelSummary page 2…Common / usual name Hydrogel dressing Proprietary name Neutrogena MD™ Cream with Glycerin « SoloSite Dermal Wound Gel (Smith & Nephew, K932263) + Spand-Gel Wound Gel (K864124, Medi-Tech International) Neutrogena MD™ Cream with Glycerin is a hydrogel wound dressing composed primarily of water and glycer… | 1986 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All MGQ devicesMGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MGQ
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MGQ
Too few MGQ 510(k)s in any year since 2007 to give a median.
Recalls per year · MGQ
4in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MGQ
5in 2025
MAUDE reports naming product code MGQ, 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 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 4 | 10 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 11 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Neutrogena MD™ Cream with Glycerin is intended for use in the management of minor burns and abrasions associated with resurfacing procedures, such as dermabrasion, chemical resurfacing, or laser resurfacing, in order to provide a moist wound environment that is supportive of healing.
For external use only. Not intended for use on 3rd degree burns.
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/K982577 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982577: Neufinish Resurfacing Cream.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982577
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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