510(k) · Cleared
ClearedManuka IG
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 May 23, 2012 as substantially equivalent to K110042 (Manuka Medical Limited, 2011) after a 51-day review. Its family tree reaches back 7 generations to 2007. 1 later device descends from it.
- Decided
- May 23, 2012
- Review
- 51 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K053095 (2007). 16 ancestors in all, the oldest K935096 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK053095 Honey Alginate DressingDerma Sciences Canada, Inc. · 2007 · Recalled
- 6 generations backK072956 Medihoney Primary Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2007
- 5 generations backK080315 Derma Sciences Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2008 · Recalled
- 4 generations backK081584 Derma Sciences Otc Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2008
- 3 generations backK092689 Manukapli Wound DressingManuka Medical Limited · 2010
- 2 generations backK102659 Manukahd, Manukahd Rope, Manukahd BorderManuka Medical Limited · 2010
- 1 generation backK110042 ManukatexManuka Medical Limited · 2011
- This deviceK120976 Manuka IGLinks Medical Products, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK133934 Manuka Foam HC, Manuka Foam HC (with Acrylic Adhesive Border)…Links Medical Products, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K133934Manuka Foam HC, Manuka Foam HC (with Acrylic Adhesive Border), Manuka Foam HC (with…Links Medical Products, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K053095 | Honey Alginate Dressing | Derma Sciences Canada, Inc. | 2007 | 1 |
| −6 | K072956 | Medihoney Primary Dressings with Active Manuka Honey | Derma Sciences, Inc. | 2007 | — |
| −5 | K080315 | Derma Sciences Medihoney Dressings with Active Manuka Honey | Derma Sciences, Inc. | 2008 | 3 |
| −4 | K081584 | Derma Sciences Otc Medihoney Dressings with Active Manuka Honey | Derma Sciences, Inc. | 2008 | — |
| −3 | K092689 | Manukapli Wound Dressing | Manuka Medical Limited | 2010 | — |
| −2 | K102659 | Manukahd, Manukahd Rope, Manukahd Border | Manuka Medical Limited | 2010 | — |
| −1 | K110042 | Manukatex | Manuka Medical Limited | 2011 | — |
| 0 (this device) | K120976 | Manuka IG | Links Medical Products, Inc. | 2012 | — |
| +1 | K133934 | Manuka Foam HC, Manuka Foam HC (with Acrylic Adhesive Border), Manuka Foam HC… | Links Medical Products, Inc. | 2014 | — |
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 |
|---|---|---|
| 2014 | 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 |
|---|---|---|---|
| * | K110042 | ManukatexSummary page 1…Device Class: Unclassified Product Code: FRO Predicate Device: MANUKAtex Wound Dressing (Manuka Medical, Ltd.) Predicate 510(k) #: K 110042 Device Description: MANUKA 10 wound dressings are sterile, single-use wound care dressings for us… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133934 | Manuka Foam HC, Manuka Foam HC (with Acrylic Adhesive Border), Manuka Foam HC (with… | 2014 | 0 |
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 5 years and passes through 4 companies; a new generation was cleared every 6 months on median.
- 2 of the 16 ancestors have a recall of any class.
- Of its descendants, K133934 (Links Medical Products, Inc., 2014) has gone furthest, with 0 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. 2012, 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 IG wound dressings are sterile, single-use, wound care dressings for use in moist wound management. MANUKA IG wound dressings may be used Over-The-Counter for:
>Minor Abrasions
> Lacerations
SMinor Cuts
> Minor Scalds and Bums
Under the supervision of a healthcare professional, MANUKA LU wound dressings may be used for:
)~Leg Ulcers
SPressure Ulcers
> I"t and 2 dDegree Burns (Superficial and Partial Thickness)
> Diabetic Foot Ulcers
>' Surgical Wounds
> Traumatic Wounds
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120976 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120976: Manuka IG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120976
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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