510(k) · Cleared
ClearedBiafine Wound Dressing Emulsion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medix Pharmaceuticals Americas, Inc. · MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Cleared on Jan 22, 1997 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 76 later devices descend from it.
- Decided
- Jan 22, 1997
- Review
- 90 days
- Class
- Class U
- Product code
- MGQ
- Recalls
- None
- Predicates
- 0
76 later devices descend from it, 13 citing it directly.
- This deviceK964240 Biafine Wound Dressing EmulsionMedix Pharmaceuticals Americas, Inc. · 1997
- Descendant · cites it directly · 67 of its ownK024367 Sinclair Wound and Skin EmulsionSinclair Pharmaceuticals, Ltd. · 2003
- Descendant · cites it directly · 44 of its ownK041342 Impruv a.I. Cream Wound and Skin EmulsionStiefel Laboratories, Inc. · 2005
- Descendant · 2 generations on · 17 of its ownK102945 Pediacyn Atopic Dermatitis HydrogelOculus Innovative Sciences, Inc. · 2011
- Descendant · cites it directly · 16 of its ownK052643 EpiceramCeragenix Corporation · 2006
- Descendant · 3 generations on · 11 of its ownK123071 Vashe Skin and Wound HydrogelPuricore, Inc. · 2013
Showing 5 of 76 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 76 · See all- K024367Sinclair Wound and Skin EmulsionSinclair Pharmaceuticals, Ltd. · 2003 · cites it directly67descendants
- K041342Impruv a.I. Cream Wound and Skin EmulsionStiefel Laboratories, Inc. · 2005 · cites it directly44descendants
- K102945Pediacyn Atopic Dermatitis HydrogelOculus Innovative Sciences, Inc. · 2011 · 2 generations on17descendants
- K052643EpiceramCeragenix Corporation · 2006 · cites it directly16descendants
- K123071Vashe Skin and Wound HydrogelPuricore, Inc. · 2013 · 3 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964240 | Biafine Wound Dressing Emulsion | Medix Pharmaceuticals Americas, Inc. | 1997 | — |
| +1 | K024367 | Sinclair Wound and Skin Emulsion | Sinclair Pharmaceuticals, Ltd. | 2003 | — |
| +1 | K041342 | Impruv a.I. Cream Wound and Skin Emulsion | Stiefel Laboratories, Inc. | 2005 | — |
| +2 | K102945 | Pediacyn Atopic Dermatitis Hydrogel | Oculus Innovative Sciences, Inc. | 2011 | — |
| +1 | K052643 | Epiceram | Ceragenix Corporation | 2006 | — |
| +3 | K123071 | Vashe Skin and Wound Hydrogel | Puricore, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 5 | 0 |
| 2009 | 8 | 0 |
| 2010 | 5 | 0 |
| 2011 | 7 | 0 |
| 2012 | 6 | 0 |
| 2013 | 5 | 0 |
| 2014 | 1 | 0 |
| 2015 | 8 | 0 |
| 2016 | 4 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2024 | 5 | 0 |
| 2025 | 3 | 0 |
| 2026 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (76)
See all 7613 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K024367 | Sinclair Wound and Skin Emulsion | 2003 | 67 |
| K041342 | Impruv a.I. Cream Wound and Skin Emulsion | 2005 | 44 |
| K052643 | Epiceram | 2006 | 16 |
| K060272 | Locobase Wound and Skin Emulsion | 2007 | 10 |
| K070309 | Neosalus | 2008 | 5 |
| K173549 | Biafine | 2018 | 4 |
| K090337 | Tropazone Lotion | 2009 | 3 |
| K110172 | Sonafine Wound Dressing | 2011 | 2 |
| K093544 | Tropazone CR | 2010 | 1 |
| K122595 | Hydropermeate Topical Emulsion, ANSWER2SKIN Sunburn Relief Cream, ANSWER2SKIN First Aid… | 2013 | 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?
- Of its descendants, K024367 (Sinclair Pharmaceuticals, Ltd., 2003) has gone furthest, with 67 descendants of its own.
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?
BIAFINE™ is intended to be used as a wound dressing for the following indications:
superficial wounds
minor abrasions
leg ulcers
donor sites
1st and 2nd degree burns, including sunburns
radiation dermatitis
for dermal ulcers, including full thickness wounds and pressure sores, consult a physician
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964240 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964240: Biafine Wound Dressing Emulsion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964240
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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