510(k) · Cleared
ClearedL.a.M. Ipm Wound Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
L.A.M. Pharmaceutical, Corp. · MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Cleared on Apr 15, 2002 as substantially equivalent to K984413 (Fidia Pharmaceutical Corp., 1999) and 1 other predicate after a 74-day review. Its family tree reaches back 2 generations to 1983. 1 of the 65 devices in its family, counting itself, has a Class I recall. 59 later devices descend from it.
- Decided
- Apr 15, 2002
- Review
- 74 days
- Class
- Class U
- Product code
- MGQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K830708 (1983). 5 ancestors in all. 59 later devices descend from it, 4 citing it directly. 1 of the 65 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK830708 Duo Derm Flex Hydroactive Dressings &Convatec, A Division of E.R. Squibb & Sons · 1983
- 1 generation backK984413 Bionect HydrogelFidia Pharmaceutical Corp. · 1999
- This deviceK020325 L.a.M. Ipm Wound GelL.A.M. Pharmaceutical, Corp. · 2002
- Descendant · cites it directly · 56 of its ownK090725 Oculus Microcyn Wound GelOculus Innovative Sciences, Inc. · 2009
- Descendant · 2 generations on · 31 of its ownK100918 Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010
- Descendant · 3 generations on · 25 of its ownK123072 Vashe Wound Therapy SolutionPuricore, Inc. · 2013
- Descendant · 2 generations on · 25 of its ownK093585 Microcyn Skin and Wound HydrogelOculus Innovative Sciences, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 20 of its ownK093697 Vashe Wound Therapy SolutionPuricore, Inc. · 2010
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K123113 L.a.M. Imp Wound Gelcites it directly · 2012
Most influential descendants
Showing 5 of 59 · See all- K090725Oculus Microcyn Wound GelOculus Innovative Sciences, Inc. · 2009 · cites it directly56descendants
- K100918Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010 · 2 generations on31descendants
- K123072Vashe Wound Therapy SolutionPuricore, Inc. · 2013 · 3 generations on25descendants
- K093585Microcyn Skin and Wound HydrogelOculus Innovative Sciences, Inc. · 2010 · 2 generations on25descendants
- K093697Vashe Wound Therapy SolutionPuricore, Inc. · 2010 · 2 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K830708 | Duo Derm Flex Hydroactive Dressings & | Convatec, A Division of E.R. Squibb & Sons | 1983 | — |
| −1 | K984413 | Bionect Hydrogel | Fidia Pharmaceutical Corp. | 1999 | — |
| 0 (this device) | K020325 | L.a.M. Ipm Wound Gel | L.A.M. Pharmaceutical, Corp. | 2002 | — |
| +1 | K090725 | Oculus Microcyn Wound Gel | Oculus Innovative Sciences, Inc. | 2009 | — |
| +2 | K100918 | Vashe Wound Therapy System Model: 9000-0014 | Puricore, Inc. | 2010 | — |
| +3 | K123072 | Vashe Wound Therapy Solution | Puricore, Inc. | 2013 | — |
| +2 | K093585 | Microcyn Skin and Wound Hydrogel | Oculus Innovative Sciences, Inc. | 2010 | 1 |
| +2 | K093697 | Vashe Wound Therapy Solution | Puricore, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 1 |
| 2013 | 3 | 0 |
| 2014 | 6 | 0 |
| 2015 | 7 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 5 | 0 |
| 2025 | 4 | 0 |
| 2026 | 9 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K984413 | Bionect HydrogelSummary page 1…cutical, Corp. Date: January 30, 2002 Device Name: L.AM, IPM™ Wound Gel Classification Name: Hydrogel Wound and Burn Dressing Predicate Device: 1(3i0noct® IIydroge! (K984413) (Fidia Pharmaceutical orp.) ITA Absorbent Wound Dressing (K984388) (Convalec) Description: L.AM. IPM™ Wound Gel is a clear vis… | 1999 |
| * | K984388 | HA Absorbent Wound DressingSummary page 1…d Gel Classification Name: Hydrogel Wound and Burn Dressing Predicate Device: 1(3i0noct® IIydroge! (K984413) (Fidia Pharmaceutical orp.) ITA Absorbent Wound Dressing (K984388) (Convalec) Description: L.AM. IPM™ Wound Gel is a clear viscous, odorlcss, aqueous gel composed principally of sodium hyalurona… | 1999 |
What descends from it? (59)
See all 594 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K123113L.a.M. Imp Wound GelGlycobiosciences, Inc. · 2012 · Cites it directly · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 15.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K090725 (Oculus Innovative Sciences, Inc., 2009) has gone furthest, with 56 descendants of its own.
- 2 other devices also cite its predicate K984413.
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?
Over-the-counter use of L.A.M. IPM Wound Gel is suitable for minor abrasions and minor cuts. Under the supervision of a healthcare professional, L.A.M. IPM Wound Gel is suitable for exuding wounds such as leg ulcers, pressure ulcers, diabetic ulcers, and for the management of mechanically or surgically debrided wounds.
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/K020325 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020325: L.a.M. Ipm Wound Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020325
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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