510(k) · Cleared
ClearedBioaquacare, Model C-10( Various Sizes) with and Without Gauze, Blister Packaged or in Plastic Bag Containers
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 Dec 21, 2007 after a 147-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Dec 21, 2007
- Review
- 147 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK072068 Bioaquacare, Model C-10( Various Sizes) with and Without Gauze…Bioartificial Gel Technologies (Bagtech), Inc. · 2007
- Descendant · cites it directly · 3 of its ownK131796 Manuka Fill Wound DressingLinks Medical Products, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 2 of its ownK173911 Medline Burn and Wound DressingMedline Industries, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK254191 IWD-Gel™InnovaCorium, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK190224 Medline Burn and Wound Dressing (OTC)Medline Industries, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK133934 Manuka Foam HC, Manuka Foam HC (with Acrylic Adhesive Border)…Links Medical Products, Inc. · 2014
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K131796Manuka Fill Wound DressingLinks Medical Products, Inc. · 2014 · cites it directly3descendants
- K173911Medline Burn and Wound DressingMedline Industries, Inc. · 2018 · 2 generations on2descendants
- K254191IWD-Gel™InnovaCorium, Inc. · 2026 · 3 generations on0descendants
- K190224Medline Burn and Wound Dressing (OTC)Medline Industries, Inc. · 2019 · 3 generations on0descendants
- K133934Manuka Foam HC, Manuka Foam HC (with Acrylic Adhesive Border), Manuka Foam HC (with…Links Medical Products, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K072068 | Bioaquacare, Model C-10( Various Sizes) with and Without Gauze, Blister… | Bioartificial Gel Technologies (Bagtech), Inc. | 2007 | — |
| +1 | K131796 | Manuka Fill Wound Dressing | Links Medical Products, Inc. | 2014 | 1 |
| +2 | K173911 | Medline Burn and Wound Dressing | Medline Industries, Inc. | 2018 | — |
| +3 | K254191 | IWD-Gel™ | InnovaCorium, Inc. | 2026 | — |
| +3 | K190224 | Medline Burn and Wound Dressing (OTC) | Medline Industries, Inc. | 2019 | — |
| +1 | K133934 | Manuka Foam HC, Manuka Foam HC (with Acrylic Adhesive Border), Manuka Foam HC… | Links Medical Products, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | — | Xylos Corporation's XCelI® Antimicrobial Wound Dressing Named without a submission number | |
| * | — | AcryMed Inc.'s AcryDerm Gel Wound Dressing Named without a submission number |
What descends from it? (6)
3 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?
- Of its descendants, K131796 (Links Medical Products, Inc., 2014) has gone furthest, with 3 descendants of its own.
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?
BioAquaCare TM is an 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. BioAquaCare TM 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…
Read the full statement (164 words)
BioAquaCare TM is an 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. BioAquaCare TM 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 burns, 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, BioAquaCareTM is indicated for the local management of: (1) chronic wounds such as pressure ulcers, lower extremity ulcers, venous ulcers, arterial ulcers, and diabetic ulcers; and (2) 2nd degree burns and donor sites.
BioAquaCare TM is intended for single use only.
BioAquaCareTM is not intended for treatment of third degree burns.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072068 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072068: Bioaquacare, Model C-10( Various Sizes) with and Without Gauze, Blister Packaged or in Plastic Bag Containers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072068
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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