510(k) · Cleared
ClearedPuraDerm Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3-D Matrix, Inc. · FRO Dressing, Wound, Drug
Cleared on Feb 13, 2015 as substantially equivalent to K973806 (Convatec, A Bristol-Myers Squibb Co., 1997) and 1 other predicate after a 112-day review. Its family tree reaches back 2 generations to 1989. 3 later devices descend from it.
- Decided
- Feb 13, 2015
- Review
- 112 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K894541 (1989). 4 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK894541 Carrington Dermal Wound GelCarrington Laboratories, Inc. · 1989
- 1 generation backK991202 Modification to Woun'dresColoplast Corp. · 1999
- This deviceK143058 PuraDerm Gel3-D Matrix, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK182681 AC5 Topical GelArch Therapeutics, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK193085 PuraDERM Gel3-D Matrix, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK190129 AC5 Topical GelArch Therapeutics, Inc. · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K894541 | Carrington Dermal Wound Gel | Carrington Laboratories, Inc. | 1989 | — |
| −1 | K991202 | Modification to Woun'dres | Coloplast Corp. | 1999 | — |
| 0 (this device) | K143058 | PuraDerm Gel | 3-D Matrix, Inc. | 2015 | — |
| +1 | K182681 | AC5 Topical Gel | Arch Therapeutics, Inc. | 2018 | — |
| +1 | K193085 | PuraDERM Gel | 3-D Matrix, Inc. | 2020 | — |
| +2 | K190129 | AC5 Topical Gel | Arch Therapeutics, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 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? (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 |
|---|---|---|---|
| * | K973806 | Duoderm Hydroactive GelSummary page 4…cation Name: Dressing, Unclassified device Product Code: FRO 3. Predicate Devices Primary Predicate: DuoDerm® Hydroactive® Gel (ConvaTec); K973806 Secondary Predicate: Woun’Dres® Collagen Hydrogel (Coloplast); K991202… | 1997 |
| * | K991202 | Modification to Woun'dresSummary page 4…FRO 3. Predicate Devices Primary Predicate: DuoDerm® Hydroactive® Gel (ConvaTec); K973806 Secondary Predicate: Woun’Dres® Collagen Hydrogel (Coloplast); K991202 K143058… | 1999 |
What descends from it? (3)
2 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 26 years and passes through 3 companies; a new generation was cleared every 15.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K182681 (Arch Therapeutics, Inc., 2018) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K973806.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
OTC:
PuraDerm is used for the management of minor cuts, abrasions, minor wounds and minor burns (1st degree burns).
Rx:
Under the supervision of a health care professional PuraDerm is used for the management of partial and full-thickness wounds, such as pressure sores, leg ulcers, diabetic ulcers, and surgical wounds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143058 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143058: PuraDerm Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143058
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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