510(k) · Cleared
ClearedCalgitrol AG Silver Alginate Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Adri · FRO Dressing, Wound, Drug
Cleared on Nov 15, 2002 after a 539-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.
- Decided
- Nov 15, 2002
- Review
- 539 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 4 citing it directly.
- This deviceK011618 Calgitrol AG Silver Alginate Wound DressingAdri · 2002
- Descendant · cites it directly · 2 of its ownK041268 Silversite or CalgitrolAdri · 2004
- Descendant · cites it directly · 1 of its ownK053590 Silverlon CA (Calcium Alginate)Argentum Medical, LLC · 2006
- Descendant · 2 generations on · 0 of its ownK192478 LT Antibacterial Alginate with Silver DressingZhejiang Longterm Medical Technology Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK173072 Algidex Ag Silver Alginate Wound DressingDeroyal Industries, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK142962 PROTOCOL Incision DressingDeroyal Industries · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K041268Silversite or CalgitrolAdri · 2004 · cites it directly2descendants
- K053590Silverlon CA (Calcium Alginate)Argentum Medical, LLC · 2006 · cites it directly1descendant
- K192478LT Antibacterial Alginate with Silver DressingZhejiang Longterm Medical Technology Co., Ltd. · 2020 · 2 generations on0descendants
- K173072Algidex Ag Silver Alginate Wound DressingDeroyal Industries, Inc. · 2018 · cites it directly0descendants
- K142962PROTOCOL Incision DressingDeroyal Industries · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011618 | Calgitrol AG Silver Alginate Wound Dressing | Adri | 2002 | — |
| +1 | K041268 | Silversite or Calgitrol | Adri | 2004 | — |
| +1 | K053590 | Silverlon CA (Calcium Alginate) | Argentum Medical, LLC | 2006 | — |
| +2 | K192478 | LT Antibacterial Alginate with Silver Dressing | Zhejiang Longterm Medical Technology Co., Ltd. | 2020 | — |
| +1 | K173072 | Algidex Ag Silver Alginate Wound Dressing | Deroyal Industries, Inc. | 2018 | — |
| +1 | K142962 | PROTOCOL Incision Dressing | Deroyal Industries | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K041268 (Adri, 2004) has gone furthest, with 2 descendants of its own.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Pressure ulcers, Srages I-ZV
Dermal lesions (or secreting skin injuries)
Venous ulcers, Srasis ulcers
l H and 2"6degree burns; donor sites
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K011618 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011618: Calgitrol AG Silver Alginate Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011618
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026