510(k) · Cleared
ClearedManukapli Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Manuka Medical Limited · FRO Dressing, Wound, Drug
Cleared on May 20, 2010 as substantially equivalent to K081584 (Derma Sciences, Inc., 2008) after a 260-day review. Its family tree reaches back 4 generations to 2007. 10 later devices descend from it.
- Decided
- May 20, 2010
- Review
- 260 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K053095 (2007). 13 ancestors in all, the oldest K935096 (1994). 10 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK053095 Honey Alginate DressingDerma Sciences Canada, Inc. · 2007 · Recalled
- 3 generations backK072956 Medihoney Primary Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2007
- 2 generations backK080315 Derma Sciences Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2008 · Recalled
- 1 generation backK081584 Derma Sciences Otc Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2008
- This deviceK092689 Manukapli Wound DressingManuka Medical Limited · 2010
- Descendant · cites it directly · 4 of its ownK121227 Manuka FillLinks Medical Products, Inc. · 2012
- Descendant · 2 generations on · 3 of its ownK131796 Manuka Fill Wound DressingLinks Medical Products, Inc. · 2014 · Recalled
- Descendant · cites it directly · 3 of its ownK102659 Manukahd, Manukahd Rope, Manukahd BorderManuka Medical Limited · 2010
- Descendant · 3 generations on · 2 of its ownK173911 Medline Burn and Wound DressingMedline Industries, Inc. · 2018
- Descendant · cites it directly · 2 of its ownK110042 ManukatexManuka Medical Limited · 2011
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K121227Manuka FillLinks Medical Products, Inc. · 2012 · cites it directly4descendants
- K131796Manuka Fill Wound DressingLinks Medical Products, Inc. · 2014 · 2 generations on3descendants
- K102659Manukahd, Manukahd Rope, Manukahd BorderManuka Medical Limited · 2010 · cites it directly3descendants
- K173911Medline Burn and Wound DressingMedline Industries, Inc. · 2018 · 3 generations on2descendants
- K110042ManukatexManuka Medical Limited · 2011 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K053095 | Honey Alginate Dressing | Derma Sciences Canada, Inc. | 2007 | 1 |
| −3 | K072956 | Medihoney Primary Dressings with Active Manuka Honey | Derma Sciences, Inc. | 2007 | — |
| −2 | K080315 | Derma Sciences Medihoney Dressings with Active Manuka Honey | Derma Sciences, Inc. | 2008 | 3 |
| −1 | K081584 | Derma Sciences Otc Medihoney Dressings with Active Manuka Honey | Derma Sciences, Inc. | 2008 | — |
| 0 (this device) | K092689 | Manukapli Wound Dressing | Manuka Medical Limited | 2010 | — |
| +1 | K121227 | Manuka Fill | Links Medical Products, Inc. | 2012 | — |
| +2 | K131796 | Manuka Fill Wound Dressing | Links Medical Products, Inc. | 2014 | 1 |
| +1 | K102659 | Manukahd, Manukahd Rope, Manukahd Border | Manuka Medical Limited | 2010 | — |
| +3 | K173911 | Medline Burn and Wound Dressing | Medline Industries, Inc. | 2018 | — |
| +1 | K110042 | Manukatex | Manuka Medical Limited | 2011 | — |
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 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 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? (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 |
|---|---|---|---|
| * | K081584 | Derma Sciences Otc Medihoney Dressings with Active Manuka HoneySummary page 1…7, 2009 Manukapli Wound Dressing Dressing, Wound ‘Dressing, Wound, Drug Unclassified FRO N/A . Derma Sciences Medihoney 100% Honey Dressings with Active Manuka Honey K081584 Manukapli Wound Dressing consists of a sterile wound - dressing designed to promote a moist wound healing environment. The devic… | 2008 |
What descends from it? (10)
4 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?
- The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 6 months on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K121227 (Links Medical Products, Inc., 2012) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K081584.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
Manukapli Wound Dressings are sterile, single-use wound care dressings for use in moist wound management. Manukapli Wound Dressings may be used Over-The-Counter for:
Minor Abrasions
Lacerations
Minor Cuts
Minor Scalds and Burns
Under the supervision of a healthcare professional, Manukapli Wound Dressings may be used for:
Leg Ulcers
Pressure Ulcers
1st and 2nd Degree Burns (superficial and Partial Thickness)
Diabetic Foot Ulcers
Surgical Wounds
Traumatic Wounds
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/K092689 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092689: Manukapli Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092689
Report an extraction error
Are you the manufacturer?
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