510(k) · Cleared
ClearedHealadex-P
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healagenics, Inc. · FRO Dressing, Wound, Drug
Cleared on Feb 16, 2007 as substantially equivalent to K983362 (Johnson & Johnson Medical, Inc., 1998) and 2 other predicates after an 87-day review. Its family tree reaches back 3 generations to 1997. 3 later devices descend from it.
- Decided
- Feb 16, 2007
- Review
- 87 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K973688 (1997). 6 ancestors in all, the oldest K894541 (1989). 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK973688 Duoderm Control Gel Formula Border DressingConvatec, Ltd. · 1997
- 2 generations backK983362 NU-Gel * Wound DressingJohnson & Johnson Medical, Inc. · 1998
- 1 generation backK022995 Collatek HydrogelBiocore Medical Technologies, Inc. · 2002
- This deviceK063517 Healadex-PHealagenics, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK221218 Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK241225 Silverlon® Wound Contact, Burn Contact DressingArgentum Medical, LLC · 2024
- Descendant · cites it directly · 0 of its ownK080471 Radio BioaquacareBioartificial Gel Technologies (Bagtech), Inc. · 2008
Most influential descendants
Showing 3 of 3 · See all- K221218Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, Inc. · 2022 · cites it directly1descendant
- K241225Silverlon® Wound Contact, Burn Contact DressingArgentum Medical, LLC · 2024 · 2 generations on0descendants
- K080471Radio BioaquacareBioartificial Gel Technologies (Bagtech), Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K973688 | Duoderm Control Gel Formula Border Dressing | Convatec, Ltd. | 1997 | — |
| −2 | K983362 | NU-Gel * Wound Dressing | Johnson & Johnson Medical, Inc. | 1998 | — |
| −1 | K022995 | Collatek Hydrogel | Biocore Medical Technologies, Inc. | 2002 | — |
| 0 (this device) | K063517 | Healadex-P | Healagenics, Inc. | 2007 | — |
| +1 | K221218 | Silverlon Wound Contact, Burn Contact Dressings | Argentum Medical, Inc. | 2022 | — |
| +2 | K241225 | Silverlon® Wound Contact, Burn Contact Dressing | Argentum Medical, LLC | 2024 | — |
| +1 | K080471 | Radio Bioaquacare | Bioartificial Gel Technologies (Bagtech), Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K983362 | NU-Gel * Wound DressingSummary page 1…y equivalent to the following approved products in indications, and to Gelita-spon Absorbable Gelatin sponge for porcine biornaterial source. vNu-Gel Wound Dressing (K983362) manufactured by Johnson &Johnson Medical Inc., H-EALAGENICS®, Inc. Premarket Notification… | 1998 |
| * | K022995 | Collatek HydrogelSummary page 2…actured by Johnson &Johnson Medical Inc., H-EALAGENICS®, Inc. Premarket Notification Submission HEALADEX®-P Collatek Hydrogel (K022995) manufactured by Biocore Medical Technologies, Inc Woun'Dres Collagen Hydrogel Wound Dressing (K991202) manufactured by C… | 2002 |
| * | K991202 | Modification to Woun'dresSummary page 2…et Notification Submission HEALADEX®-P Collatek Hydrogel (K022995) manufactured by Biocore Medical Technologies, Inc Woun'Dres Collagen Hydrogel Wound Dressing (K991202) manufactured by Coloplast Corporation Indications for Use HEALADEX®-P Wound Dressing provides a moist environment… | 1999 |
| * | — | Gelita-spon Absorbable Gelatin sponge Named without a submission number |
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 10 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K221218 (Argentum Medical, Inc., 2022) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K983362.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
HEALADEX®-P Wound Dressing provides a moist environment that is supportive of wound healing. HEALADEX-P is indicated for dry, light and moderately exudating partial and full thickness wounds such as:
First and second degree burns
Severe sunburns
Superficial injuries, superficial lacerations, cuts, abrasions, incisions/surgical wounds, and skin tears
HEALADEX-P dressing should be used under health care professional direction for the following indications:
Pressure ulcers, Stage I-JV
Lower extremity ulcers
Venous ulcers
Arterial ulcers
Ulcers of mixed etiology
Diabetic ulcers
Donor sites and skin grafts
Burns caused by radiation oncology procedures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063517 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063517: Healadex-P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063517
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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