510(k) · Cleared

Cleared

L-Mesitran Dressing Family II- Soft and Tulle

K150676510(k) TraditionalCleared Dec 23, 2015282-day reviewClass U

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

Theo Manufacturing BV · FRO Dressing, Wound, Drug

Cleared on Dec 23, 2015 as substantially equivalent to K053613 (Theo Manufacturing BV, 2007) and 1 other predicate after a 282-day review. Its family tree reaches back 5 generations to 2007.

Decided: Dec 23, 2015
Review: 282 days
Class: Class U
Product code: FRO
Recalls: None
Predicates: 2

Its longest line of descent runs back 5 generations to K053095 (2007). 16 ancestors in all, the oldest K872165 (1987). No later device cites it as a predicate yet.

By dateBy generation

Root · 5 generations backK053095 Honey Alginate DressingDerma Sciences Canada, Inc. · 2007 · Recalled
4 generations backK072956 Medihoney Primary Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2007
3 generations backK080315 Derma Sciences Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2008 · Recalled
2 generations backK081584 Derma Sciences Otc Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2008
1 generation backK101793 Medihoney Gel Dressing with Active Manuka HoneyDerma Sciences, Inc. · 2011 · Recalled
This deviceK150676 L-Mesitran Dressing Family II- Soft and TulleTheo Manufacturing BV · 2015

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K053095	Honey Alginate Dressing	Derma Sciences Canada, Inc.	2007	1
−4	K072956	Medihoney Primary Dressings with Active Manuka Honey	Derma Sciences, Inc.	2007	—
−3	K080315	Derma Sciences Medihoney Dressings with Active Manuka Honey	Derma Sciences, Inc.	2008	3
−2	K081584	Derma Sciences Otc Medihoney Dressings with Active Manuka Honey	Derma Sciences, Inc.	2008	—
−1	K101793	Medihoney Gel Dressing with Active Manuka Honey	Derma Sciences, Inc.	2011	4
0 (this device)	K150676	L-Mesitran Dressing Family II- Soft and Tulle	Theo Manufacturing BV	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1987	1	0
1994	2	0
1995	1	0
1996	1	0
1999	2	0
2002	1	0
2006	1	0
2007	1	0
2008	1	0

FIG. 1 — Lineage of K150676, 2007–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K053613	L-Mesitran Hydro, L-Mesitran Border, L-Mesitran Net, L-Mesitran Active Summary page 4 …lassified Classification Code: Dressing, Product Code FRO Panel: General & Plastic Surgery 3. Predicate Devices #K053613 L-Mesitran® Dressing Family I : L-Mesitran® Hydro, Border, Active and Net…	Theo Manufacturing BV	2007	—
*	K101793	Medihoney Gel Dressing with Active Manuka Honey Summary page 4 …s #K053613 L-Mesitran® Dressing Family I : L-Mesitran® Hydro, Border, Active and Net #K101793 Derma Sciences Medihoney Gel Dressings with Active Manuka Honey 4. Device Description L-Mesitran®…	Derma Sciences, Inc.	2011	4

Also cleared against K053613: 1 other device →

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 8 years and passes through 3 companies; a new generation was cleared every 6 months on median.
4 of the 16 ancestors have a recall of any class.
1 other device also cites its predicate K053613.

How does its category compare?

All FRO devices

FRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · FRO

11in 2025

2007high 31 (2009) · low 8 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRO

176in 2025

2007high 332 (2022) · low 96 (2012)2026

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

Recalls per year · FRO

2in 2024

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

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

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?

a) Over-The-Counter (OTC) use The L-Mesitran Dressing Family II – Soft and Tulle provide a moist environment conducive to wound healing and are indicated for light to moderately exuding wounds. For over the counter use, L-Mesitran Dressing Family II may be used for: - minor abrasions - lacerations - minor cuts - minor scalds and burns b) Prescription (Rx) use Under the supervision of a healthcare professional, The L-Mesitran Dressing Family II – Soft and…

Read the full statement (163 words)

a) Over-The-Counter (OTC) use

The L-Mesitran Dressing Family II – Soft and Tulle provide a moist environment conducive to wound healing and are indicated for light to moderately exuding wounds. For over the counter use, L-Mesitran Dressing Family II may be used for:

- minor abrasions

- lacerations

- minor cuts

- minor scalds and burns

b) Prescription (Rx) use

Under the supervision of a healthcare professional, The L-Mesitran Dressing Family II – Soft and Tulle provide a moist environment conducive to wound healing and are indicated for light to moderately exuding wounds. The L-Mesitran Dressing Family II is intended for the management of the following:

- 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 burns

- Donor sites, and traumatic and surgical wounds

L-Mesitran Soft and Tulle are to be used in conjunction with other secondary dressings.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K150676 · printed Nov 6, 2026

Cite this page

510(k) Report. “K150676: L-Mesitran Dressing Family II- Soft and Tulle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150676

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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