510(k) · Cleared
ClearedHydrolyzed Collagen/AG Wound Gel with Silver
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Hymed Group Corp. · FRO Dressing, Wound, Drug
Cleared on Jun 19, 2014 as substantially equivalent to K073019 (Argentis Biomedical Incorporated, 2008) after a 276-day review. Its family tree reaches back 6 generations to 1997.
- Decided
- Jun 19, 2014
- Review
- 276 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K973688 (1997). 19 ancestors in all, the oldest K894541 (1989). No later device cites it as a predicate yet.
- Root · 6 generations backK973688 Duoderm Control Gel Formula Border DressingConvatec, Ltd. · 1997
- 5 generations backK983362 NU-Gel * Wound DressingJohnson & Johnson Medical, Inc. · 1998
- 4 generations backK022995 Collatek HydrogelBiocore Medical Technologies, Inc. · 2002
- 3 generations backK040019 SilversealNoble Fiber Technologies · 2004
- 2 generations backK061227 Hydrolyzed Collagen/AG Wound Gel with SilverThe Hymed Group Corp. · 2006
- 1 generation backK073019 Silvermed Antimicrobial Silver HydrogelArgentis Biomedical Incorporated · 2008
- This deviceK132891 Hydrolyzed Collagen/AG Wound Gel with SilverThe Hymed Group Corp. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K973688 | Duoderm Control Gel Formula Border Dressing | Convatec, Ltd. | 1997 | — |
| −5 | K983362 | NU-Gel * Wound Dressing | Johnson & Johnson Medical, Inc. | 1998 | — |
| −4 | K022995 | Collatek Hydrogel | Biocore Medical Technologies, Inc. | 2002 | — |
| −3 | K040019 | Silverseal | Noble Fiber Technologies | 2004 | — |
| −2 | K061227 | Hydrolyzed Collagen/AG Wound Gel with Silver | The Hymed Group Corp. | 2006 | — |
| −1 | K073019 | Silvermed Antimicrobial Silver Hydrogel | Argentis Biomedical Incorporated | 2008 | — |
| 0 (this device) | K132891 | Hydrolyzed Collagen/AG Wound Gel with Silver | The Hymed Group Corp. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2001 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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? (1)
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 |
|---|---|---|---|
| * | K073019 | Silvermed Antimicrobial Silver HydrogelSummary page 1…available also as an Over-The-Counter (OTC) wound care product substantially equivalent to SilverMed Antinicerobial Wound Gel which was approved for OTC and lix use via K073019. identification of piredicate devices to which substantial equivalence is being claimedan for which approval was srnuted for bot… | 2008 |
| † | K061227 | Hydrolyzed Collagen/AG Wound Gel with Silver | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 17 years and passes through 6 companies; a new generation was cleared every 2.4 years on median.
- None of the 19 ancestors has a recall.
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?
Indications for Over-the-Counter Use: Hydrolyzed Collagen/Ag Wound Gel is indicated for the management of minor bums, superficial cuts, lacerations, abrasions and minor irritation of the skin.
Indications for Prescription Use: Under the supervision of a healthcare professional, it is indicated for partial and full thickness wounds including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree bums, abrasions, lacerations, skin tears, grafted wounds, donor sites and surgical wounds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132891 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132891: Hydrolyzed Collagen/AG Wound Gel with Silver.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132891
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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