510(k) · Cleared
ClearedModification of Bionect Clear Hydrogel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fidia Pharmaceutical Corp. · MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Cleared on Feb 10, 1999 after an 85-day review. The FDA summary names its predicate without a number. 23 later devices descend from it.
- Decided
- Feb 10, 1999
- Review
- 85 days
- Class
- Class U
- Product code
- MGQ
- Recalls
- None
- Predicates
- 0
23 later devices descend from it, 2 citing it directly.
- This deviceK984264 Modification of Bionect Clear HydrogelFidia Pharmaceutical Corp. · 1999
- Descendant · cites it directly · 21 of its ownK080010 Nocc Hydrophilic Wound DressingKytogenics, Inc. · 2008
- Descendant · 2 generations on · 14 of its ownK081584 Derma Sciences Otc Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2008
- Descendant · 3 generations on · 10 of its ownK092689 Manukapli Wound DressingManuka Medical Limited · 2010
- Descendant · 2 generations on · 5 of its ownK112191 Healex Biosponge Wound DressingBionova Medical, Inc. · 2012
- Descendant · 3 generations on · 4 of its ownK123961 Sentrex Biosponge MPDBionova Medical, Inc. · 2013
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K080010Nocc Hydrophilic Wound DressingKytogenics, Inc. · 2008 · cites it directly21descendants
- K081584Derma Sciences Otc Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2008 · 2 generations on14descendants
- K092689Manukapli Wound DressingManuka Medical Limited · 2010 · 3 generations on10descendants
- K112191Healex Biosponge Wound DressingBionova Medical, Inc. · 2012 · 2 generations on5descendants
- K123961Sentrex Biosponge MPDBionova Medical, Inc. · 2013 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K984264 | Modification of Bionect Clear Hydrogel | Fidia Pharmaceutical Corp. | 1999 | — |
| +1 | K080010 | Nocc Hydrophilic Wound Dressing | Kytogenics, Inc. | 2008 | — |
| +2 | K081584 | Derma Sciences Otc Medihoney Dressings with Active Manuka Honey | Derma Sciences, Inc. | 2008 | — |
| +3 | K092689 | Manukapli Wound Dressing | Manuka Medical Limited | 2010 | — |
| +2 | K112191 | Healex Biosponge Wound Dressing | Bionova Medical, Inc. | 2012 | — |
| +3 | K123961 | Sentrex Biosponge MPD | Bionova Medical, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 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 MGQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | — | BIONECT® Hydrogel Named without a submission number |
What descends from it? (23)
See all 232 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, K080010 (Kytogenics, Inc., 2008) has gone furthest, with 21 descendants of its own.
How does its category compare?
All MGQ devicesMGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MGQ
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MGQ
Too few MGQ 510(k)s in any year since 2007 to give a median.
Recalls per year · MGQ
4in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MGQ
5in 2025
MAUDE reports naming product code MGQ, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 4 | 10 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 11 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
BIONECT® Hydrogel, Gauze Pads, Foam, Spray, and Clear Hydrogel are indicated for the dressing and management of minor burns: superficial cuts, lacerations, and abrasions; and minor irritations of the skin. A health care professional may be consulted prior to the first use of these products to determine whether these conditions exist. BIONECT® Hydrogel, Gauze Pads, Foam, Spray, and Clear Hydrogel may also be used under the care of a health care professional for wounds such as partial to full thickness dermal ulcers (pressure ulcers, venous stasis ulcers, arterial ulcers, diabetic ulcers), surgical wounds (post-operative incisions and donor sites), and second degree burns.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984264 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984264: Modification of Bionect Clear Hydrogel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984264
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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