510(k) · Cleared
ClearedRadio Bioaquacare
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioartificial Gel Technologies (Bagtech), Inc. · FRO Dressing, Wound, Drug
Cleared on Mar 5, 2008 as substantially equivalent to K072068 (Bioartificial Gel Technologies (Bagtech), Inc., 2007) and 3 other predicates after a 13-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Mar 5, 2008
- Review
- 13 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K961758 (1996). 14 ancestors in all, the oldest K894541 (1989). No later device cites it as a predicate yet.
- Root · 4 generations backK961758 Carasyn Hydrogel Wound ProductsCarrington Laboratories, Inc. · 1996
- 3 generations backK024367 Sinclair Wound and Skin EmulsionSinclair Pharmaceuticals, Ltd. · 2003
- 2 generations backK041342 Impruv a.I. Cream Wound and Skin EmulsionStiefel Laboratories, Inc. · 2005
- 1 generation backK052643 EpiceramCeragenix Corporation · 2006
- This deviceK080471 Radio BioaquacareBioartificial Gel Technologies (Bagtech), Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K961758 | Carasyn Hydrogel Wound Products | Carrington Laboratories, Inc. | 1996 | — |
| −3 | K024367 | Sinclair Wound and Skin Emulsion | Sinclair Pharmaceuticals, Ltd. | 2003 | — |
| −2 | K041342 | Impruv a.I. Cream Wound and Skin Emulsion | Stiefel Laboratories, Inc. | 2005 | — |
| −1 | K052643 | Epiceram | Ceragenix Corporation | 2006 | — |
| 0 (this device) | 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 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K072068 | Bioaquacare, Model C-10( Various Sizes) with and Without Gauze, Blister Packaged or in…Summary page 1…Dressing, Wound, Drug Classification Unclassified Product Code FRO Predicate Devices BioArtificial Gel Technologies, hic.'s BioAquaCare m (K(072068) AcryMed Inc.'s AcryDerm Gel Wound Dressing (K970693) Ceragenix Corporation's Epiceram Skin Baffler Emulsion (K0526… | 2007 |
| * | K970693 | Acryderm Gel Wound DressingSummary page 1…d Product Code FRO Predicate Devices BioArtificial Gel Technologies, hic.'s BioAquaCare m (K(072068) AcryMed Inc.'s AcryDerm Gel Wound Dressing (K970693) Ceragenix Corporation's Epiceram Skin Baffler Emulsion (K052643) Healagenics, Inc.'s Healadex-P Occlusive Dressing… | 1997 |
| * | K052643 | EpiceramSummary page 1…Technologies, hic.'s BioAquaCare m (K(072068) AcryMed Inc.'s AcryDerm Gel Wound Dressing (K970693) Ceragenix Corporation's Epiceram Skin Baffler Emulsion (K052643) Healagenics, Inc.'s Healadex-P Occlusive Dressing (K(0635 17) Intended Use / Indications for Use… | 2006 |
| * | K063517 | Healadex-P | 2007 |
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 12 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- None of the 14 ancestors has a recall.
- 2 other devices also cite its predicate K072068.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
Radio BioAquaCareTM is a hydrogel wound dressing intended for the management of wounds and provides a moist environment that supports the autolytic debridement of areas of the wound that are necrotic. Radio BioAquaCare M T wound dressing provides an effective barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. It is intended for use with dry, light, and moderately exuding partial and…
Read the full statement (171 words)
Radio BioAquaCareTM is a hydrogel wound dressing intended for the management of wounds and provides a moist environment that supports the autolytic debridement of areas of the wound that are necrotic. Radio BioAquaCare M T wound dressing provides an effective barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. It is intended for use with dry, light, and moderately exuding partial and full-thickness wounds such as minor bums, superficial injuries, lacerations, cuts, abrasions, incisions and surgical wounds, and skin tears. The dressing also protects against abrasion, desiccation, and external contamination. The moist environment has a cooling effect that may reduce pain.
Under the direction of a health care professional, Radio BioAquaCareTM is indicated for the local management of: (1) chronic wounds such as pressure ulcers, lower extremity ulcers, venous ulcers, arterial ulcers, diabetic ulcers, radiation dermatitis, and (2) 2Md degree bums and donor sites.
Radio BioAquaCareTM is intended for single use only. Radio BioAquaCare M T is not intended for treatment of third degree bums.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080471 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080471: Radio Bioaquacare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080471
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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