510(k) · Cleared
ClearedMicrolyte Ag
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imbed Biosciences, Inc. · FRO Dressing, Wound, Drug
Cleared on Aug 4, 2016 as substantially equivalent to K080383 (Convatec, A Division of E.R. Squibb & Sons, LLC, 2008) and 2 other predicates after a 218-day review. Its family tree reaches back 4 generations to 1992. 1 later device descends from it.
- Decided
- Aug 4, 2016
- Review
- 218 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K914604 (1992). 12 ancestors in all, the oldest K890354 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK914604 Mepitel Non-Adherent Silicone DressingMolnlycke Clinical Products AB · 1992
- 3 generations backK984371 Mepitel Non Adherent Silicone DressingMolnlycke Health Care, Inc. · 1999
- 2 generations backK063271 Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver…Convatec, A Division of E.R. Squibb & Sons, LLC · 2007
- 1 generation backK080383 Aquacel Hydrofiber Wound Dressing and AG Hydrofiber DressingConvatec, A Division of E.R. Squibb & Sons, LLC · 2008
- This deviceK153756 Microlyte AgImbed Biosciences, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK211943 Microlyte Ag/LidocaineImbed Biosciences · 2024
Most influential descendants
Showing 1 of 1 · See all- K211943Microlyte Ag/LidocaineImbed Biosciences · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K914604 | Mepitel Non-Adherent Silicone Dressing | Molnlycke Clinical Products AB | 1992 | — |
| −3 | K984371 | Mepitel Non Adherent Silicone Dressing | Molnlycke Health Care, Inc. | 1999 | — |
| −2 | K063271 | Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver Impregnated… | Convatec, A Division of E.R. Squibb & Sons, LLC | 2007 | — |
| −1 | K080383 | Aquacel Hydrofiber Wound Dressing and AG Hydrofiber Dressing | Convatec, A Division of E.R. Squibb & Sons, LLC | 2008 | — |
| 0 (this device) | K153756 | Microlyte Ag | Imbed Biosciences, Inc. | 2016 | — |
| +1 | K211943 | Microlyte Ag/Lidocaine | Imbed Biosciences | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (3)
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 |
|---|---|---|---|
| * | K080383 | Aquacel Hydrofiber Wound Dressing and AG Hydrofiber DressingSummary page 5…ant requirements of ISO 10993. III. PREDICATE DEVICES: AQUACEL® Ag with Hydrofiber® Silver Impregnated Antimicrobial Dressing; K080383 AcryDerm® (or SilvaSorb®) Silver Antimicrobial Dressing; K002599… | 2008 |
| * | K002599 | Modification to Acryderm Silver Antimicrobial Wound Dressing, Models 1041, 1042, 1043…Summary page 5…er Impregnated Antimicrobial Dressing; K080383 AcryDerm® (or SilvaSorb®) Silver Antimicrobial Dressing; K002599 Silverlon™ Contact Wound Dressing; K981299 IV. INTENDED USE: Microlyte™ Ag wound dressing is in… | 2000 |
| * | K981299 | Silverlon Contact Wound DressingSummary page 5…383 AcryDerm® (or SilvaSorb®) Silver Antimicrobial Dressing; K002599 Silverlon™ Contact Wound Dressing; K981299 IV. INTENDED USE: Microlyte™ Ag wound dressing is indicated for the management of wounds and can be used over-the- counter for m… | 1998 |
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 |
|---|---|---|---|
| K211943 | Microlyte Ag/Lidocaine | 2024 | 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 24 years and passes through 4 companies; a new generation was cleared every 8.1 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K211943 (Imbed Biosciences, 2024) has gone furthest, with 0 descendants of its own.
- 14 other devices also cite its predicate K080383.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
Under the supervision of a healthcare professional,
Microlyte™ Ag wound dressing may be used for the management of:
-Wounds,
-Partial and full thickness wounds including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree
burns, abrasions and lacerations, donor sites and surgical wounds,
-May be used over debrided and grafted partial thickness wounds.
For over-the-counter use,
Microlyte™ Ag wound dressing may be used for: abrasions, lacerations, minor cuts, and minor scalds and burns.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153756 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153756: Microlyte Ag.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153756
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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