510(k) · Cleared
ClearedLT Antibacterial Alginate with Silver Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhejiang Longterm Medical Technology Co., Ltd. · FRO Dressing, Wound, Drug
Cleared on Jun 17, 2020 as substantially equivalent to K172570 (Foshan United Medical Technologies, Ltd., 2018) and 1 other predicate after a 281-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- Jun 17, 2020
- Review
- 281 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K914604 (1992). 17 ancestors in all, the oldest K914575 (1991). No later device cites it as a predicate yet.
- Root · 6 generations backK914604 Mepitel Non-Adherent Silicone DressingMolnlycke Clinical Products AB · 1992
- 5 generations backK984371 Mepitel Non Adherent Silicone DressingMolnlycke Health Care, Inc. · 1999
- 4 generations backK063271 Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver…Convatec, A Division of E.R. Squibb & Sons, LLC · 2007
- 3 generations backK080383 Aquacel Hydrofiber Wound Dressing and AG Hydrofiber DressingConvatec, A Division of E.R. Squibb & Sons, LLC · 2008
- 2 generations backK121275 Aquacel AG Extra Hydrofiber Dressing with Silver and Strengthening…Convatec, Inc. · 2012
- 1 generation backK172570 ALGS6 Ag Alginate Wound DressingFoshan United Medical Technologies, Ltd. · 2018
- This deviceK192478 LT Antibacterial Alginate with Silver DressingZhejiang Longterm Medical Technology Co., Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K914604 | Mepitel Non-Adherent Silicone Dressing | Molnlycke Clinical Products AB | 1992 | — |
| −5 | K984371 | Mepitel Non Adherent Silicone Dressing | Molnlycke Health Care, Inc. | 1999 | — |
| −4 | K063271 | Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver Impregnated… | Convatec, A Division of E.R. Squibb & Sons, LLC | 2007 | — |
| −3 | K080383 | Aquacel Hydrofiber Wound Dressing and AG Hydrofiber Dressing | Convatec, A Division of E.R. Squibb & Sons, LLC | 2008 | — |
| −2 | K121275 | Aquacel AG Extra Hydrofiber Dressing with Silver and Strengthening Fiber | Convatec, Inc. | 2012 | — |
| −1 | K172570 | ALGS6 Ag Alginate Wound Dressing | Foshan United Medical Technologies, Ltd. | 2018 | — |
| 0 (this device) | K192478 | LT Antibacterial Alginate with Silver Dressing | Zhejiang Longterm Medical Technology Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 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? (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 | Decided |
|---|---|---|---|
| * | K172570 | ALGS6 Ag Alginate Wound DressingSummary page 4…el: General and Plastic Surgery Product Code: FRO Class: Unclassified Predicate Devices: K172570 ALGS6 Ag Alginate Wound Dressing (Foshan United Medical Technologies, Ltd.)… | 2018 |
| * | K053590 | Silverlon CA (Calcium Alginate)Summary page 4…dicate Devices: K172570 ALGS6 Ag Alginate Wound Dressing (Foshan United Medical Technologies, Ltd.) K053590 Silverlon CA Calcium Alginate Dressing-Antibacterial Silver (Argentum LLC) 2 Devi… | 2006 |
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 28 years and passes through 6 companies; a new generation was cleared every 5.8 years on median.
- 1 of the 17 ancestors has a recall of any class.
- 1 other device also cites its predicate K172570.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
LT Antibacterial Alginate with Silver Dressing is used for management acute and chronic wounds, partial and full thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, pressure ulcers, donor and graft sites, surgical wounds, traumatic wounds, first and second-degree burns.
LT Antibacterial Alginate with Silver Dressing is intended for external use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192478 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192478: LT Antibacterial Alginate with Silver Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192478
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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