510(k) Report

510(k) · Cleared

Cleared

Advancis Activon Tube

K101114510(k) TraditionalCleared Jul 26, 2011461-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Advancis Medical · FRO Dressing, Wound, Drug

Cleared on Jul 26, 2011 as substantially equivalent to K102478 (Southwest Technologies, Inc., 2010) and 4 other predicates after a 461-day review. Its family tree reaches back 5 generations to 2007.

Decided
Jul 26, 2011
Review
461 days
Class
Class U
Product code
FRO
Recalls
None
Predicates
5

Its longest line of descent runs back 5 generations to K053095 (2007). 17 ancestors in all, the oldest K872165 (1987). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2010: 1 other ancestor2009: 1 other ancestor2008: 1 other ancestor2006: 1 other ancestor2002: 1 other ancestor1999: 2 other ancestors1987: 1 other ancestor1996: 1 other ancestor1995: 1 other ancestor1994: 2 other ancestorsK053095 · Honey Alginate Dressing · Derma Sciences Canada, Inc. · 2007 · recalledK072956 · Medihoney Primary Dressings with Active Manuka Honey · Derma Sciences, Inc. · 2007×2: 2 generations cleared close together, K080315 (2008), K081584 (2008) K092689 · Manukapli Wound Dressing · Manuka Medical Limited · 2010198519901995200020052010
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 5 other ancestors3 generations back: 5 other ancestors K092689 · Manukapli Wound Dressing · Manuka Medical Limited · 2010K081584 · Derma Sciences Otc Medihoney Dressings with Active Manuka Honey · Derma Sciences, Inc. · 2008K080315 · Derma Sciences Medihoney Dressings with Active Manuka Honey · Derma Sciences, Inc. · 2008 · recalledK072956 · Medihoney Primary Dressings with Active Manuka Honey · Derma Sciences, Inc. · 2007K053095 · Honey Alginate Dressing · Derma Sciences Canada, Inc. · 2007 · recalled−50
  1. Root · 5 generations backK053095 Honey Alginate DressingDerma Sciences Canada, Inc. · 2007 · Recalled
  2. 4 generations backK072956 Medihoney Primary Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2007
  3. 3 generations backK080315 Derma Sciences Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2008 · Recalled
  4. 2 generations backK081584 Derma Sciences Otc Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2008
  5. 1 generation backK092689 Manukapli Wound DressingManuka Medical Limited · 2010
  6. This deviceK101114 Advancis Activon TubeAdvancis Medical · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K053095Honey Alginate DressingDerma Sciences Canada, Inc.20071
−4K072956Medihoney Primary Dressings with Active Manuka HoneyDerma Sciences, Inc.2007—
−3K080315Derma Sciences Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc.20083
−2K081584Derma Sciences Otc Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc.2008—
−1K092689Manukapli Wound DressingManuka Medical Limited2010—
0 (this device)K101114Advancis Activon TubeAdvancis Medical2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
199420
199510
199610
199920
200210
200610
200810
200910
201010
FIG. 1 — Lineage of K101114, 2007–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K261023 Microdacyn Wound Irrigation Solutionscore 15.5 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K102478Otc Elasto-Gel Manuka Honey Wound Dressing
Cleared while this submission was under review
Summary page 2
…ses Manuka honey from a tube, essentially identically in technology and indications to Activon Tube TM Sterile 100% Manuka Honey. The additional predicate devices (K102478, K092689, K083334, K081584) are substantially identical to Activon Tube TM Sterile 100% Manuka Honey in their use of active…
Southwest Technologies, Inc.2010—
*K092689Manukapli Wound Dressing
Cleared while this submission was under review
Summary page 1
…ney wound dressings: 0 OTC Elasto-Gel Manuka Honey Wound Dressing Ki102478 0 Manukapli Wound Dressing K092689 0 Elasto-Gel Manuka Honey Wound Dressing K083334 0 Derma Sciences OTC Medihoney Dr…
Manuka Medical Limited2010—
*K083334Elasto-Gel Manuka Honey Wound Dressing
Summary page 1
…ssing Ki102478 0 Manukapli Wound Dressing K092689 0 Elasto-Gel Manuka Honey Wound Dressing K083334 0 Derma Sciences OTC Medihoney Dressings With Active Manuka Honey…
Southwest Technologies, Inc.2009—
*K081584Derma Sciences Otc Medihoney Dressings with Active Manuka Honey
Summary page 1
…y Wound Dressing K083334 0 Derma Sciences OTC Medihoney Dressings With Active Manuka Honey K081584 * Medihoney Active Manuka (Leptospermurn) 100% Honey dispensed from a tube…
Derma Sciences, Inc.2008—
*K080315Derma Sciences Medihoney Dressings with Active Manuka Honey
Summary page 1
…y K081584 * Medihoney Active Manuka (Leptospermurn) 100% Honey dispensed from a tube K0803 15 101U9y 4. Device Description Ac…
Derma Sciences, Inc.20083

What descends from it?

No later submission names this one as a predicate yet.

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 4 years and passes through 4 companies; a new generation was cleared every 6 months on median.
  • 3 of the 17 ancestors have a recall of any class.

How does its category compare?

All FRO devices

FRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · FRO

11in 2025

2007: 292008: 262009: 312010: 312011: 272012: 242013: 192014: 222015: 282016: 282017: 232018: 202019: 162020: 122021: 82022: 92023: 182024: 242025: 112026 (partial year): 17
2007high 31 (2009) · low 8 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRO

176in 2025

2007: 187 days median2008: 130 days median2009: 136 days median2010: 146 days median2011: 177 days median2012: 96 days median2013: 194 days median2014: 214 days median2015: 249 days median2016: 222 days median2017: 147 days median2018: 206 days median2019: 270 days median2020: 226 days median2021: 275 days median2022: 332 days median2023: 283 days median2024: 263 days median2025: 176 days median2026 (partial year): 254 days median
2007high 332 (2022) · low 96 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FRO

2in 2024

2007: 42008: 12009: 12011: 42013: 12014: 12015: 22016: 32017: 12019: 12021: 62022: 22023: 2, 2 Class I2024: 22026 (partial year): 2
2007high 6 (2021) · low 0 (2010)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · FRO

192in 2025

2007: 552008: 302009: 452010: 1222011: 422012: 652013: 1392014: 2692015: 2972016: 1472017: 1492018: 1282019: 1362020: 1392021: 1832022: 1762023: 1982024: 2322025: 192
2007high 297 (2015) · low 30 (2008)2025

MAUDE reports naming product code FRO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200729187455
200826130130
200931136145
2010311460122
201127177442
20122496065
2013191941139
2014222141269
2015282492297
2016282223147
2017231471149
2018202060128
2019162701136
2020122260139
202182756183
202293322176
2023182832 (2)198
2024242632232
2025111760192
2026172542—

What is it indicated for?

OTC: For minor wounds, minor ulcerations, minor bums, minor abraded skin, and minor irritated areas.

Professional: Intended in the management of:

* diabetic foot ulcers;

* leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology);

* pressure ulcers/sores (partial and full thickness);

* 1st and 2nd degree partial thickness bums;

* grafted and donor sites and traumatic and surgical wounds.

Indications for use as stated in the FDA summary.

Recent decisions in FRO

The FRO category page

  • K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbH · 2026
  • K254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLC · 2026
  • K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd. · 2026
  • K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC · 2026
  • K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc. · 2026

https://510kreport.com/device/K101114 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101114: Advancis Activon Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101114

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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