510(k) · Cleared
ClearedNocc Hydrophilic Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kytogenics, Inc. · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Mar 14, 2008 as substantially equivalent to K984264 (Fidia Pharmaceutical Corp., 1999) after a 71-day review. Its family tree reaches back 1 generation to 1999. 21 later devices descend from it.
- Decided
- Mar 14, 2008
- Review
- 71 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K984264 (1999). 21 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK984264 Modification of Bionect Clear HydrogelFidia Pharmaceutical Corp. · 1999
- This deviceK080010 Nocc Hydrophilic Wound DressingKytogenics, Inc. · 2008
- Descendant · cites it directly · 14 of its ownK081584 Derma Sciences Otc Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2008
- Descendant · 2 generations on · 10 of its ownK092689 Manukapli Wound DressingManuka Medical Limited · 2010
- Descendant · cites it directly · 5 of its ownK112191 Healex Biosponge Wound DressingBionova Medical, Inc. · 2012
- Descendant · 2 generations on · 4 of its ownK123961 Sentrex Biosponge MPDBionova Medical, Inc. · 2013
- Descendant · 3 generations on · 4 of its ownK121227 Manuka FillLinks Medical Products, Inc. · 2012
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K081584Derma Sciences Otc Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2008 · cites it directly14descendants
- K092689Manukapli Wound DressingManuka Medical Limited · 2010 · 2 generations on10descendants
- K112191Healex Biosponge Wound DressingBionova Medical, Inc. · 2012 · cites it directly5descendants
- K123961Sentrex Biosponge MPDBionova Medical, Inc. · 2013 · 2 generations on4descendants
- K121227Manuka FillLinks Medical Products, Inc. · 2012 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K984264 | Modification of Bionect Clear Hydrogel | Fidia Pharmaceutical Corp. | 1999 | — |
| 0 (this device) | K080010 | Nocc Hydrophilic Wound Dressing | Kytogenics, Inc. | 2008 | — |
| +1 | K081584 | Derma Sciences Otc Medihoney Dressings with Active Manuka Honey | Derma Sciences, Inc. | 2008 | — |
| +2 | K092689 | Manukapli Wound Dressing | Manuka Medical Limited | 2010 | — |
| +1 | K112191 | Healex Biosponge Wound Dressing | Bionova Medical, Inc. | 2012 | — |
| +2 | K123961 | Sentrex Biosponge MPD | Bionova Medical, Inc. | 2013 | — |
| +3 | K121227 | Manuka Fill | Links Medical Products, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2018 | 1 | 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 KGN? 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 KGN device
- #1 K231325 Corplex P / Theracor P / Allacor Pscore 17.9 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K984264 | Modification of Bionect Clear HydrogelSummary page 1…: MGQ, dressing, wound and bum, hydrogel w/drug and/or biologic Predicate Devices: Bionect Clear Hydrogel, Fidia Pharmaceutical (K984264) Device Description NOCCrm (N,O-Carboxymethylchitosan) Hydrophilic Wound Dressing is a hydrogel that provides a moist wound envir… | 1999 |
What descends from it? (21)
See all 212 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?
How does its category compare?
All KGN devicesKGN Wound Dressing With Animal-Derived Material (S): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · KGN
15so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · KGN
162in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGN
3in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KGN
15in 2025
MAUDE reports naming product code KGN, 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 | 3 | 32 | 0 | 0 |
| 2008 | 6 | 87 | 0 | 1 |
| 2009 | 8 | 121 | 0 | 2 |
| 2010 | 4 | 175 | 0 | 3 |
| 2011 | 7 | 228 | 0 | 6 |
| 2012 | 8 | 123 | 0 | 4 |
| 2013 | 6 | 147 | 0 | 6 |
| 2014 | 5 | 188 | 0 | 12 |
| 2015 | 7 | 87 | 0 | 9 |
| 2016 | 4 | 164 | 0 | 6 |
| 2017 | 7 | 136 | 1 | 8 |
| 2018 | 6 | 148 | 3 | 15 |
| 2019 | 3 | 128 | 0 | 11 |
| 2020 | 5 | 279 | 0 | 17 |
| 2021 | 6 | 236 | 0 | 14 |
| 2022 | 12 | 246 | 0 | 13 |
| 2023 | 9 | 194 | 0 | 21 |
| 2024 | 13 | 83 | 0 | 15 |
| 2025 | 10 | 162 | 0 | 15 |
| 2026 | 15 | 174 | 0 | — |
What is it indicated for?
Hydrophilic Wound Dressing is indicated in the dressing and management of minor burns, superficial cuts, lacerations, and abrasions; minor irritations of the skin. A health care professional may be consulted prior to the first use of the product to determine whether these conditions exist. Kytogenics' Hydrophilic Wound Dressing may also be used under the care of a health care professional for wounds such as partial thickness dermal ulcers (pressure sores, venous stasis ulcers, diabetic ulcers), surgical wounds (post operative incisions and donor sites, and second degree bums.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080010 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080010: Nocc Hydrophilic Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080010
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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