510(k) · Cleared
ClearedBionect 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 as substantially equivalent to K945835 (Telios Pharmaceuticals, Inc., 1995) and 2 other predicates after an 85-day review. Its family tree reaches back 1 generation to 1983. 1 of the 64 devices in its family, counting itself, has a Class I recall. 60 later devices descend from it.
- Decided
- Feb 10, 1999
- Review
- 85 days
- Class
- Class U
- Product code
- MGQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K830708 (1983). 3 ancestors in all. 60 later devices descend from it, 3 citing it directly. 1 of the 64 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK830708 Duo Derm Flex Hydroactive Dressings &Convatec, A Division of E.R. Squibb & Sons · 1983
- This deviceK984413 Bionect HydrogelFidia Pharmaceutical Corp. · 1999
- Descendant · cites it directly · 59 of its ownK020325 L.a.M. Ipm Wound GelL.A.M. Pharmaceutical, Corp. · 2002
- Descendant · 2 generations on · 56 of its ownK090725 Oculus Microcyn Wound GelOculus Innovative Sciences, Inc. · 2009
- Descendant · 3 generations on · 31 of its ownK100918 Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010
- Descendant · 4 generations on · 25 of its ownK123072 Vashe Wound Therapy SolutionPuricore, Inc. · 2013
- Descendant · 3 generations on · 25 of its ownK093585 Microcyn Skin and Wound HydrogelOculus Innovative Sciences, Inc. · 2010 · Recalled
Showing 5 of 60 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K123113 L.a.M. Imp Wound Gelcites it directly · 2012
Most influential descendants
Showing 5 of 60 · See all- K020325L.a.M. Ipm Wound GelL.A.M. Pharmaceutical, Corp. · 2002 · cites it directly59descendants
- K090725Oculus Microcyn Wound GelOculus Innovative Sciences, Inc. · 2009 · 2 generations on56descendants
- K100918Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010 · 3 generations on31descendants
- K123072Vashe Wound Therapy SolutionPuricore, Inc. · 2013 · 4 generations on25descendants
- K093585Microcyn Skin and Wound HydrogelOculus Innovative Sciences, Inc. · 2010 · 3 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K830708 | Duo Derm Flex Hydroactive Dressings & | Convatec, A Division of E.R. Squibb & Sons | 1983 | — |
| 0 (this device) | K984413 | Bionect Hydrogel | Fidia Pharmaceutical Corp. | 1999 | — |
| +1 | K020325 | L.a.M. Ipm Wound Gel | L.A.M. Pharmaceutical, Corp. | 2002 | — |
| +2 | K090725 | Oculus Microcyn Wound Gel | Oculus Innovative Sciences, Inc. | 2009 | — |
| +3 | K100918 | Vashe Wound Therapy System Model: 9000-0014 | Puricore, Inc. | 2010 | — |
| +4 | K123072 | Vashe Wound Therapy Solution | Puricore, Inc. | 2013 | — |
| +3 | K093585 | Microcyn Skin and Wound Hydrogel | Oculus Innovative Sciences, Inc. | 2010 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 1 |
| 2013 | 3 | 0 |
| 2014 | 6 | 0 |
| 2015 | 7 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 5 | 0 |
| 2025 | 4 | 0 |
| 2026 | 9 | 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.
1 device in this family has a Class I recall. 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? (3)
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 |
|---|---|---|---|
| * | K945835 | Argidene (TM) GelSummary page 2…T® Hydrogel is substantially equivalent in function and intended use to the following commercially available non-interactive wound and burn dressings: . Argidene™ Gel (K945835) (Telios Pharmaceuticals, Inc.) . Carrasyn™ Hydrogel Wound Dressing (K902345) (Carrington Laboratories, Inc.) . DuoDERM Hydroacti… | 1995 |
| * | K902345 | Carrington Wound DressingSummary page 2…following commercially available non-interactive wound and burn dressings: . Argidene™ Gel (K945835) (Telios Pharmaceuticals, Inc.) . Carrasyn™ Hydrogel Wound Dressing (K902345) (Carrington Laboratories, Inc.) . DuoDERM Hydroactive™ Gel (K830708) (ConvaTec.) Device description Explanation of how the dev… | 1990 |
| * | K830708 | Duo Derm Flex Hydroactive Dressings &Summary page 2…ings: . Argidene™ Gel (K945835) (Telios Pharmaceuticals, Inc.) . Carrasyn™ Hydrogel Wound Dressing (K902345) (Carrington Laboratories, Inc.) . DuoDERM Hydroactive™ Gel (K830708) (ConvaTec.) Device description Explanation of how the device functions: Since it is a hydrogel, BIONECT® Hydrogel provides a2… | 1983 |
What descends from it? (60)
See all 603 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K123113L.a.M. Imp Wound GelGlycobiosciences, Inc. · 2012 · Cites it directly · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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 Clcar Hydrogel arc 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 Clcar Hyvdrogel may also be used under the carc of a health care professional for wounds such as partial 1o 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/K984413 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984413: Bionect Hydrogel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984413
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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