510(k) · Cleared

Recalled · Class I · 2014

L.a.M. Imp Wound Gel

K123113510(k) TraditionalCleared Dec 11, 201269-day reviewClass URecalls 1 (1 Class I)

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Glycobiosciences, Inc. · FRO Dressing, Wound, Drug

Cleared on Dec 11, 2012 as substantially equivalent to K984413 (Fidia Pharmaceutical Corp., 1999) and 1 other predicate after a 69-day review. Its family tree reaches back 3 generations to 1983. 1 of the 9 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled once, including a Class I recall.

Decided: Dec 11, 2012
Review: 69 days
Class: Class U
Product code: FRO
Recalls: 1 (1 Class I)
Predicates: 2

Its longest line of descent runs back 3 generations to K830708 (1983). 6 ancestors in all. 2 later devices descend from it, 1 citing it directly. 1 of the 9 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 3 generations backK830708 Duo Derm Flex Hydroactive Dressings &Convatec, A Division of E.R. Squibb & Sons · 1983
2 generations backK984413 Bionect HydrogelFidia Pharmaceutical Corp. · 1999
1 generation backK020325 L.a.M. Ipm Wound GelL.A.M. Pharmaceutical, Corp. · 2002
This deviceK123113 L.a.M. Imp Wound GelGlycobiosciences, Inc. · 2012
Descendant · cites it directly · 1 of its ownK130781 L.a.M. Ipm Wound Gel, Ipm Derm GelGlycobiosciences, Inc. · 2014
Descendant · 2 generations on · 0 of its ownK143527 IPM Wound Gel Bio, IPM Derm Gel BioGlycobiosciences, Inc. · 2015

Most influential descendants

Showing 2 of 2 · See all

K130781L.a.M. Ipm Wound Gel, Ipm Derm GelGlycobiosciences, Inc. · 2014 · cites it directly1descendant
K143527IPM Wound Gel Bio, IPM Derm Gel BioGlycobiosciences, Inc. · 2015 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K830708	Duo Derm Flex Hydroactive Dressings &	Convatec, A Division of E.R. Squibb & Sons	1983	—
−2	K984413	Bionect Hydrogel	Fidia Pharmaceutical Corp.	1999	—
−1	K020325	L.a.M. Ipm Wound Gel	L.A.M. Pharmaceutical, Corp.	2002	—
0 (this device)	K123113	L.a.M. Imp Wound Gel	Glycobiosciences, Inc.	2012	—
+1	K130781	L.a.M. Ipm Wound Gel, Ipm Derm Gel	Glycobiosciences, Inc.	2014	—
+2	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
1995	1	0
1999	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2015	1	0

FIG. 1 — Lineage of K123113, 1983–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K984413	Bionect Hydrogel Summary page 1 …ound And Burn, Hydrogel W/Drug . And/Or Biologic Product code (classification): - Product Code FRO; Unclassified Legally Marketed Predicate Devices: Bionect® Hydrogel (K984413); February 10, 1999 L.A.M IPM Wound Gel (K020325); April 15, 2002 _ Device Description: L.A.M. IPM Wound Gel is a clear viscous…	Fidia Pharmaceutical Corp.	1999	—
*	K020325	L.a.M. Ipm Wound Gel Summary page 1 …Product code (classification): - Product Code FRO; Unclassified Legally Marketed Predicate Devices: Bionect® Hydrogel (K984413); February 10, 1999 L.A.M IPM Wound Gel (K020325); April 15, 2002 _ Device Description: L.A.M. IPM Wound Gel is a clear viscous, odorlcss, aqueous gel composed principally of s…	L.A.M. Pharmaceutical, Corp.	2002	—

Also cleared against K984413: 2 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K130781	L.a.M. Ipm Wound Gel, Ipm Derm Gel	Glycobiosciences, Inc.	2014	1

Has anything in its family been recalled? (1 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 25, 2014	Class I	Z-2112-2014	Nonconforming Material/Component	Potential for microbial contamination of the product.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 29 years and passes through 4 companies; a new generation was cleared every 10.7 years on median.
None of the 6 ancestors has a recall.
Of its descendants, K130781 (Glycobiosciences, Inc., 2014) has gone furthest, with 1 descendant of its own.
2 other devices also cite its predicate K984413.

How does its category compare?

All FRO devices

FRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · FRO

11in 2025

2007high 31 (2009) · low 8 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRO

176in 2025

2007high 332 (2022) · low 96 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FRO

2in 2024

2007high 6 (2021) · low 0 (2010)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · FRO

192in 2025

2007high 297 (2015) · low 30 (2008)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?

OTC:

L.AM. IPM Wound Gel is indicated for the management of minor burns (1st degree burns), minor abrasions and minor cuts.

Rx:

Under the supervision of a healthcare professional L.A.M. IPM Wound Gel is indicated for the 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 2nd 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/K123113 · printed Nov 6, 2026

Cite this page

510(k) Report. “K123113: L.a.M. Imp 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/K123113

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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