510(k) · Cleared
ClearedIpm Wound Gel Bio
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 Mar 3, 2014 as substantially equivalent to K984413 (Fidia Pharmaceutical Corp., 1999) and 1 other predicate after a 508-day review. Its family tree reaches back 3 generations to 1983. 1 later device descends from it.
- Decided
- Mar 3, 2014
- Review
- 508 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K830708 (1983). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 deviceK123193 Ipm Wound Gel BioGlycobiosciences, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK143527 IPM Wound Gel Bio, IPM Derm Gel BioGlycobiosciences, Inc. · 2015
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 |
|---|---|---|---|---|---|
| −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) | K123193 | Ipm Wound Gel Bio | 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 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
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.
Planning a device in FRO? 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? (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…and Bum, H-ydrogel W/Drug and/or Biologic Product code (dlassification): Product Code MGQ; Undlassified Legally Marketed Predicate Devices: Bionect® Hydrogel (K984413) L.A.M. 1PM Wound Gel (K020325)- L.A.M. 1PM Wound Gel (K020325); April 15, 2002 Device Description: IPM Wound Gel Bio… | 1999 |
| * | K020325 | L.a.M. Ipm Wound GelSummary page 1…ic Product code (dlassification): Product Code MGQ; Undlassified Legally Marketed Predicate Devices: Bionect® Hydrogel (K984413) L.A.M. 1PM Wound Gel (K020325)- L.A.M. 1PM Wound Gel (K020325); April 15, 2002 Device Description: IPM Wound Gel Bio is a dear viscous, odorless, aqueous gel… | 2002 |
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? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 4 companies; a new generation was cleared every 11.9 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K143527 (Glycobiosciences, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K984413.
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?
1PM Wound Gel Bio 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.
Rx:
Under the supervision of a health care professional:
- IPM Wound Gel Bio 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.
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/K123193 · printed Nov 4, 2026
Cite this page
510(k) Report. “K123193: Ipm Wound Gel Bio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123193
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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