510(k) · Cleared
ClearedL.a.M. Ipm Wound Gel, Ipm Derm Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Glycobiosciences, Inc. · FRO Dressing, Wound, Drug
Cleared on Feb 14, 2014 as substantially equivalent to K962218 (Carrington Laboratories, Inc., 1996) and 4 other predicates after a 330-day review. Its family tree reaches back 6 generations to 1983. 1 of the 21 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Feb 14, 2014
- Review
- 330 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K830708 (1983). 19 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 21 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK830708 Duo Derm Flex Hydroactive Dressings &Convatec, A Division of E.R. Squibb & Sons · 1983
- 5 generations backK984413 Bionect HydrogelFidia Pharmaceutical Corp. · 1999
- 4 generations backK020325 L.a.M. Ipm Wound GelL.A.M. Pharmaceutical, Corp. · 2002
- 3 generations backK090725 Oculus Microcyn Wound GelOculus Innovative Sciences, Inc. · 2009
- 2 generations backK093585 Microcyn Skin and Wound HydrogelOculus Innovative Sciences, Inc. · 2010 · Recalled
- 1 generation backK102945 Pediacyn Atopic Dermatitis HydrogelOculus Innovative Sciences, Inc. · 2011
- This deviceK130781 L.a.M. Ipm Wound Gel, Ipm Derm GelGlycobiosciences, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK143527 IPM Wound Gel Bio, IPM Derm Gel BioGlycobiosciences, Inc. · 2015
Class I recalls in this family
- K123113 L.a.M. Imp Wound Geldirect predicate · 2012
Most influential descendants
Showing 1 of 1 · See all- K143527IPM Wound Gel Bio, IPM Derm Gel BioGlycobiosciences, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K830708 | Duo Derm Flex Hydroactive Dressings & | Convatec, A Division of E.R. Squibb & Sons | 1983 | — |
| −5 | K984413 | Bionect Hydrogel | Fidia Pharmaceutical Corp. | 1999 | — |
| −4 | K020325 | L.a.M. Ipm Wound Gel | L.A.M. Pharmaceutical, Corp. | 2002 | — |
| −3 | K090725 | Oculus Microcyn Wound Gel | Oculus Innovative Sciences, Inc. | 2009 | — |
| −2 | K093585 | Microcyn Skin and Wound Hydrogel | Oculus Innovative Sciences, Inc. | 2010 | 1 |
| −1 | K102945 | Pediacyn Atopic Dermatitis Hydrogel | Oculus Innovative Sciences, Inc. | 2011 | — |
| 0 (this device) | K130781 | L.a.M. Ipm Wound Gel, Ipm Derm Gel | Glycobiosciences, Inc. | 2014 | — |
| +1 | K143527 | IPM Wound Gel Bio, IPM Derm Gel Bio | Glycobiosciences, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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.
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.
Top candidate predicates for a new FRO device
- #1 K261023 Microdacyn Wound Irrigation Solutionscore 15.5 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K962218 | Carrasyn Hydrogel Wound Dressing,Carragauze Pads,Carragauze Strips,Carrasorb M FDGSummary page 3…roduct Classification Manufacturer Classification Number Name Code Name Panel K9622 18 Canrasyn MGQ Dressing, Wound Carrngton General & ilydrogel… | 1996 |
| * | K102945 | Pediacyn Atopic Dermatitis HydrogelSummary page 1…ct code (classification): FRO Legally Marketed Predicate Devices: - Carrasyn Hydrogell Wound Dressing (K(962218); September 12, 1996 - Epicyn HydroGel (K102945); February 2, 2011 - MimyX Cream (K(041342); July 19, 2005 - L.A.M. 1PM Wound Gel (K(020325); April 15, 2002… | 2011 |
| * | K041342 | Impruv a.I. Cream Wound and Skin EmulsionSummary page 3…Dressing, Wound, Oculus Innovative General & HydroGel Drug Sciences ic. Plastic Surgery K04 1342 MbnyX Cream MGQ Dressing. Wound Stiefel. General &… | 2005 |
| * | K020325 | L.a.M. Ipm Wound GelSummary page 3…tic Hydrogel W/Dr-ug Surgery and/or Biologic K020325 L.AM. 1PM MGQ Dressing, Wound LAM General & Wound Gel… | 2002 |
| * | K123113 | L.a.M. Imp Wound GelSummary page 4…use as its predicates; Epicyn HydroGel (K102945), Carrasyn Hydrogel Wound Dressing (K962218), MimyX Cream (K041342), LAM IPM Wound Gel (K020325) and L.AM 1PM Wound Gel (K123113)listed. Ad DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143527 | IPM Wound Gel Bio, IPM Derm Gel Bio | 2015 | 0 |
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 · Direct predicate · ◆ in the 2012 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 31 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- 2 of the 19 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K143527 (Glycobiosciences, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K962218.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · FRO
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRO
176in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRO
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · FRO
192in 2025
MAUDE reports naming product code FRO, 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 | 29 | 187 | 4 | 55 |
| 2008 | 26 | 130 | 1 | 30 |
| 2009 | 31 | 136 | 1 | 45 |
| 2010 | 31 | 146 | 0 | 122 |
| 2011 | 27 | 177 | 4 | 42 |
| 2012 | 24 | 96 | 0 | 65 |
| 2013 | 19 | 194 | 1 | 139 |
| 2014 | 22 | 214 | 1 | 269 |
| 2015 | 28 | 249 | 2 | 297 |
| 2016 | 28 | 222 | 3 | 147 |
| 2017 | 23 | 147 | 1 | 149 |
| 2018 | 20 | 206 | 0 | 128 |
| 2019 | 16 | 270 | 1 | 136 |
| 2020 | 12 | 226 | 0 | 139 |
| 2021 | 8 | 275 | 6 | 183 |
| 2022 | 9 | 332 | 2 | 176 |
| 2023 | 18 | 283 | 2 (2) | 198 |
| 2024 | 24 | 263 | 2 | 232 |
| 2025 | 11 | 176 | 0 | 192 |
| 2026 | 17 | 254 | 2 | — |
What is it indicated for?
L.A.M. 1PM Wound Gel/IPM Derm Gel is indicated for management of minor burns (1st degree burns), minor abrasions, minor cuts and helps to relieve dry waxy skin irritations associated with dry skin conditions. Under the supervision of a health care professional; L.A.M. 1PM Wound Gel/IPM Derm Gel is indicated for management of exudating wounds such as leg ulcers, pressure ulcers, diabetic ulcers, surgical wounds (post-operative incisions and donor sites)…
Read the full statement (111 words)
L.A.M. 1PM Wound Gel/IPM Derm Gel is indicated for management of minor burns (1st degree burns), minor abrasions, minor cuts and helps to relieve dry waxy skin irritations associated with dry skin conditions.
Under the supervision of a health care professional;
L.A.M. 1PM Wound Gel/IPM Derm Gel is indicated for management of exudating wounds such as leg ulcers, pressure ulcers, diabetic ulcers, surgical wounds (post-operative incisions and donor sites), mechanically or surgically debrided wounds, and for second degree burns.
L.A.M. 1PM Wound Gel/IPM Derm Gel is indicated for the management and relief of burning, itching and pain associated with various types of dermatoses; including atopic dermatitis, allergic contact dermatitis and radio-dermatitis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130781 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130781: L.a.M. Ipm Wound Gel, Ipm Derm Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130781
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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