510(k) · Cleared

Cleared

L-Mesitran Hydro, L-Mesitran Border, L-Mesitran Net, L-Mesitran Active

K053613510(k) TraditionalCleared Jul 25, 2007575-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 Jul 25, 2007 as substantially equivalent to K872165 (Southwest Technologies, Inc., 1987) after a 575-day review. Its family tree reaches back 1 generation to 1987. 3 later devices descend from it.

Decided: Jul 25, 2007
Review: 575 days
Class: Class U
Product code: FRO
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K872165 (1987). 3 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK872165 Elasto-Gel Occlusive DressingSouthwest Technologies, Inc. · 1987 · Recalled
This deviceK053613 L-Mesitran Hydro, L-Mesitran Border, L-Mesitran Net, L-Mesitran ActiveTheo Manufacturing BV · 2007
Descendant · cites it directly · 1 of its ownK110546 Medihoney Hydrogel Sheet Dressings with Active Leptospermum HoneyDerma Sciences, Inc. · 2011 · Recalled
Descendant · 2 generations on · 0 of its ownK222143 Apis (R), Veris (TM)Sweetbio, Inc. · 2023
Descendant · cites it directly · 0 of its ownK150676 L-Mesitran Dressing Family II- Soft and TulleTheo Manufacturing BV · 2015

Most influential descendants

Showing 3 of 3 · See all

K110546Medihoney Hydrogel Sheet Dressings with Active Leptospermum HoneyDerma Sciences, Inc. · 2011 · cites it directly1descendant
K222143Apis (R), Veris (TM)Sweetbio, Inc. · 2023 · 2 generations on0descendants
K150676L-Mesitran Dressing Family II- Soft and TulleTheo Manufacturing BV · 2015 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K872165	Elasto-Gel Occlusive Dressing	Southwest Technologies, Inc.	1987	2
0 (this device)	K053613	L-Mesitran Hydro, L-Mesitran Border, L-Mesitran Net, L-Mesitran Active	Theo Manufacturing BV	2007	—
+1	K110546	Medihoney Hydrogel Sheet Dressings with Active Leptospermum Honey	Derma Sciences, Inc.	2011	5
+2	K222143	Apis (R), Veris (TM)	Sweetbio, Inc.	2023	—
+1	K150676	L-Mesitran Dressing Family II- Soft and Tulle	Theo Manufacturing BV	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2015	1	0
2023	1	0

FIG. 1 — Lineage of K053613, 1987–2023Source: 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K872165	Elasto-Gel Occlusive Dressing Summary page 1 …n Name: Wound Dressing Classification Code: Dressing, Product Code FRO Predicate Device: Southwest Technologies' Elasto-Gel Dressings, #K872165 Device Description: L-Mesitran Hydro, L-Mesitran Border, and L-Mesitran Active are hydro-act…	Southwest Technologies, Inc.	1987	2

Also cleared against K872165: 2 other devices →

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K110546	Medihoney Hydrogel Sheet Dressings with Active Leptospermum Honey	Derma Sciences, Inc.	2011	1
K150676	L-Mesitran Dressing Family II- Soft and Tulle	Theo Manufacturing BV	2015	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?

Its one ancestor has a recall.
Of its descendants, K110546 (Derma Sciences, Inc., 2011) has gone furthest, with 1 descendant of its own.
2 other devices also cite its predicate K872165.

How does its category compare?

All FRO devices

FRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?

L-Mesitran Hydro and L-Mesitran Border L-Mesitran Hydro and Border dressings are indicated for acute and chronic superficial wounds such as: bruises, cuts, bedsores, first and second-degree burns and other traumatic wounds, venous and arterial ulcera, diabetes ulcers, donor sites, and post-operative wounds. L-Mesitran Hydro and Border should not be used as a covering for deep narrow cavities, dirty wounds (these should first be cleansed), third-degree…

Read the full statement (172 words)

L-Mesitran Hydro and L-Mesitran Border

L-Mesitran Hydro and Border dressings are indicated for acute and chronic superficial wounds such as: bruises, cuts, bedsores, first and second-degree burns and other traumatic wounds, venous and arterial ulcera, diabetes ulcers, donor sites, and post-operative wounds.

L-Mesitran Hydro and Border should not be used as a covering for deep narrow cavities, dirty wounds (these should first be cleansed), third-degree burns and fistulae.

L-Mesitran Net

L-Mesitran Net Dressings are indicated for acute and chronic superficial wounds such as: bruises, skin tears, pressure ulcers, venous and arterial ulcera, diabetes ulcers, donor sites, cuts, first and second degree burns, postoperative wounds and other external wounds caused by trauma. L-Mesitran Net is to be used in conjunction with other secondary dressings.

It should not be used on its own as a covering for dirty, infected and heavily exudating wounds (should first be cleansed), third degree burns, or deep narrow cavities.

L-Mesitran Active

L-Mesitran Active Dressings are indicated for treating minor burns, superficial cuts, lacerations and abrasions, and other small wounds.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K053613 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053613: L-Mesitran Hydro, L-Mesitran Border, L-Mesitran Net, L-Mesitran Active.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053613

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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