510(k) · Cleared
Recalled · Class II · 2023Manuka Fill Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Links Medical Products, Inc. · FRO Dressing, Wound, Drug
Cleared on Mar 14, 2014 as substantially equivalent to K121227 (Links Medical Products, Inc., 2012) and 1 other predicate after a 269-day review. Its family tree reaches back 6 generations to 2007. 3 later devices descend from it. It has been recalled once.
- Decided
- Mar 14, 2014
- Review
- 269 days
- Class
- Class U
- Product code
- FRO
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 6 generations to K053095 (2007). 16 ancestors in all, the oldest K935096 (1994). 3 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK053095 Honey Alginate DressingDerma Sciences Canada, Inc. · 2007 · Recalled
- 5 generations backK072956 Medihoney Primary Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2007
- 4 generations backK080315 Derma Sciences Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2008 · Recalled
- 3 generations backK081584 Derma Sciences Otc Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2008
- 2 generations backK092689 Manukapli Wound DressingManuka Medical Limited · 2010
- 1 generation backK121227 Manuka FillLinks Medical Products, Inc. · 2012
- This deviceK131796 Manuka Fill Wound DressingLinks Medical Products, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK173911 Medline Burn and Wound DressingMedline Industries, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK254191 IWD-Gel™InnovaCorium, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK190224 Medline Burn and Wound Dressing (OTC)Medline Industries, Inc. · 2019
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K053095 | Honey Alginate Dressing | Derma Sciences Canada, Inc. | 2007 | 1 |
| −5 | K072956 | Medihoney Primary Dressings with Active Manuka Honey | Derma Sciences, Inc. | 2007 | — |
| −4 | K080315 | Derma Sciences Medihoney Dressings with Active Manuka Honey | Derma Sciences, Inc. | 2008 | 3 |
| −3 | K081584 | Derma Sciences Otc Medihoney Dressings with Active Manuka Honey | Derma Sciences, Inc. | 2008 | — |
| −2 | K092689 | Manukapli Wound Dressing | Manuka Medical Limited | 2010 | — |
| −1 | K121227 | Manuka Fill | Links Medical Products, Inc. | 2012 | — |
| 0 (this device) | K131796 | Manuka Fill Wound Dressing | Links Medical Products, Inc. | 2014 | — |
| +1 | K173911 | Medline Burn and Wound Dressing | Medline Industries, Inc. | 2018 | — |
| +2 | K254191 | IWD-Gel™ | InnovaCorium, Inc. | 2026 | — |
| +2 | K190224 | Medline Burn and Wound Dressing (OTC) | Medline Industries, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 2 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K121227 | Manuka FillSummary page 2…oist wound environment that promotes autolytic debridement conducive to wound healing. MANUKA FILL and its predicate (K121227) accomplish this by using 100% Leptosperinun socparium honey as the primary i… | 2012 |
| * | K072068 | Bioaquacare, Model C-10( Various Sizes) with and Without Gauze, Blister Packaged or in…Summary page 1…Wound Dressing (Links Medical Products, Inc.), BioAquaCare (RioArtificial Gel Technologies) Predicate 510(k) #: Kl2 1227 (MANUKA FILL), K072068 (BioAquaCare) Device Description: MANUKA FILL wound dressing is a sterile, single-use, wound car… | 2007 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173911 | Medline Burn and Wound Dressing | 2018 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 3, 2023 | Class II | Z-1982-2023 | Under Investigation by firm | Medline issued a recall on TheraHoney Wound Gel due to the manufacturer notifying Medline of a sterilization dose audit failure on the wound gel and not augmenting the dose after failure per ISO 11137. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 2 of the 16 ancestors have a recall of any class.
- Of its descendants, K173911 (Medline Industries, Inc., 2018) has gone furthest, with 2 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. 2014, 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?
MANUKA FILL wound dressing may be used Over-The-Counter for the management of:
> Minor Abrasions
> Minor Lacerations
> Minor Cuts
> Minor Scalds and Minor Bums
MANUKA FILL wound dressing provides a moist wound environment. A moist wound environment allows autolytic debridement of necrotic tissue.
Under the supervision of a bealthicare professional, MANUKA FILL wound dressing is indicated for the management of:
> Leg Ulcers
> Pressure Ulcers
> I"1 and 2 nd Degree Bums
> Diabetic Foot Ulcers
> Surgical Wounds
> Trauma Wounds
MANlJKA FILL wound dressing provides a moist wound environment. A moist wound environment allows autolytic debridement of necrotic tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131796 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131796: Manuka Fill Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131796
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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