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 Dec 20, 2006 as substantially equivalent to K955506 (The Hymed Group Corp., 1996) and 3 other predicates after a 232-day review. Its family tree reaches back 4 generations to 1997. 21 later devices descend from it.
- Decided
- Dec 20, 2006
- Review
- 232 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K973688 (1997). 14 ancestors in all, the oldest K894541 (1989). 21 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK973688 Duoderm Control Gel Formula Border DressingConvatec, Ltd. · 1997
- 3 generations backK983362 NU-Gel * Wound DressingJohnson & Johnson Medical, Inc. · 1998
- 2 generations backK022995 Collatek HydrogelBiocore Medical Technologies, Inc. · 2002
- 1 generation backK040019 SilversealNoble Fiber Technologies · 2004
- This deviceK061227 Hydrolyzed Collagen/AG Wound Gel with SilverThe Hymed Group Corp. · 2006
- Descendant · cites it directly · 18 of its ownK090160 Suprathel Wound and Burn DressingPolymedics Innovations, GmbH · 2009
- Descendant · 2 generations on · 10 of its ownK132397 Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc. · 2014
- Descendant · 2 generations on · 5 of its ownK142879 BTM Wound DressingPolynovo Biomaterials Pty, Ltd. · 2015
- Descendant · 3 generations on · 4 of its ownK172140 NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing…Polynovo Biomaterials Pty, Ltd. · 2017
- Descendant · 3 generations on · 4 of its ownK170300 Restrata Wound MatrixAcera Surgical, Inc. · 2017 · Recalled
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K090160Suprathel Wound and Burn DressingPolymedics Innovations, GmbH · 2009 · cites it directly18descendants
- K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc. · 2014 · 2 generations on10descendants
- K142879BTM Wound DressingPolynovo Biomaterials Pty, Ltd. · 2015 · 2 generations on5descendants
- K172140NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm)…Polynovo Biomaterials Pty, Ltd. · 2017 · 3 generations on4descendants
- K170300Restrata Wound MatrixAcera Surgical, Inc. · 2017 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K973688 | Duoderm Control Gel Formula Border Dressing | Convatec, Ltd. | 1997 | — |
| −3 | K983362 | NU-Gel * Wound Dressing | Johnson & Johnson Medical, Inc. | 1998 | — |
| −2 | K022995 | Collatek Hydrogel | Biocore Medical Technologies, Inc. | 2002 | — |
| −1 | K040019 | Silverseal | Noble Fiber Technologies | 2004 | — |
| 0 (this device) | K061227 | Hydrolyzed Collagen/AG Wound Gel with Silver | The Hymed Group Corp. | 2006 | — |
| +1 | K090160 | Suprathel Wound and Burn Dressing | Polymedics Innovations, GmbH | 2009 | — |
| +2 | K132397 | Gore Bio-a Wound Matrix | W. L. Gore & Associates, Inc. | 2014 | — |
| +2 | K142879 | BTM Wound Dressing | Polynovo Biomaterials Pty, Ltd. | 2015 | — |
| +3 | K172140 | NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x… | Polynovo Biomaterials Pty, Ltd. | 2017 | — |
| +3 | K170300 | Restrata Wound Matrix | Acera Surgical, Inc. | 2017 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2001 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K955506 | HycureSummary page 1…fication of predicate devices to which substantial equivalence is being claimed: o HyCure®R Hydrolyzed Collagen K955506 o HeliDerMTM Collagen Wound Dressing K990086 o X-Static® Silverseal Hydroge… | 1996 |
| * | K990086 | Heliderm Collagen Wound Dressings 0.5 Gram and 1.0 GramSummary page 1…d: o HyCure®R Hydrolyzed Collagen K955506 o HeliDerMTM Collagen Wound Dressing K990086 o X-Static® Silverseal Hydrogel Wound Dressing K040019 o SilvaSorb Silver Antimicrobi… | 1999 |
| * | K040019 | SilversealSummary page 1…506 o HeliDerMTM Collagen Wound Dressing K990086 o X-Static® Silverseal Hydrogel Wound Dressing K040019 o SilvaSorb Silver Antimicrobial Wound Gel K0l11994 o AcryDerm Silver Antimicrobi… | 2004 |
| * | K011994 | Acryderm Silver Anttimicrobial Wound Gel Model# a-002101Summary page 1…19 o SilvaSorb Silver Antimicrobial Wound Gel K0l11994 o AcryDerm Silver Antimicrobial Wound Dressing K01 1994 *Description of the Device: Hydrolyzed Collagen/Ag Wound Gel is a line extension of the previously approved HyCu… | 2001 |
What descends from it? (21)
See all 212 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 9 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K090160 (Polymedics Innovations, GmbH, 2009) has gone furthest, with 18 descendants of its own.
- 3 other devices also cite its predicate K955506.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Pressure ulcers (Stages I - IV)
Venous stasis ulcers
Diabetic ulcers
Ulcers resulting from arterial insufficiency
Surgical wounds
Traumatic wounds
First and second degree burns
Superficial wounds
Grafted wounds and donor sites
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061227 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061227: Hydrolyzed Collagen/AG Wound Gel with Silver.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061227
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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