510(k) · Cleared
ClearedSilversite or Calgitrol
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Adri · MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Cleared on Sep 20, 2004 as substantially equivalent to K011618 (Adri, 2002) and 2 other predicates after a 131-day review. Its family tree reaches back 2 generations to 1997. 2 later devices descend from it.
- Decided
- Sep 20, 2004
- Review
- 131 days
- Class
- Class U
- Product code
- MGQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K970566 (1997). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK970566 Arglaes Film DressingMaersk Medical, Ltd. · 1997
- 1 generation backK990810 Arglaes-AB Antimicrobial Barrier Film Dressing & Island DressingMaersk Medical, Ltd. · 1999
- This deviceK041268 Silversite or CalgitrolAdri · 2004
- Descendant · cites it directly · 0 of its ownK173072 Algidex Ag Silver Alginate Wound DressingDeroyal Industries, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK102212 D-Stat Dry Silver; D-Stat Dry Clear Silver; D-Stat Dry Wrap Silver…Vascular Solutions, Inc. · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970566 | Arglaes Film Dressing | Maersk Medical, Ltd. | 1997 | — |
| −1 | K990810 | Arglaes-AB Antimicrobial Barrier Film Dressing & Island Dressing | Maersk Medical, Ltd. | 1999 | — |
| 0 (this device) | K041268 | Silversite or Calgitrol | Adri | 2004 | — |
| +1 | K173072 | Algidex Ag Silver Alginate Wound Dressing | Deroyal Industries, Inc. | 2018 | — |
| +1 | K102212 | D-Stat Dry Silver; D-Stat Dry Clear Silver; D-Stat Dry Wrap Silver; Thrombix… | Vascular Solutions, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2018 | 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 MGQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K011618 | Calgitrol AG Silver Alginate Wound DressingSummary page 3…air *05 s FOR * : , . 0 L4I I5! A sw The predicate devices are: 1. 510(k)K011618 Calgitrol Ag Silver Alginate Foam 2. 510(k)K970566 AR… | 2002 |
| * | K970566 | Arglaes Film DressingSummary page 2…Calgitro l m I. CALGITROLTM Ag Silver Alginate Foam Dressing (KOI 1618) 2. ARGLAES-ABTM Antimicrobial Barrier Film Dressing (K970566) 3. ARGLAES-AB TM Antimicrobial Barrier Film Dressing (K990810) The device is a silver ion-containing dressing in… | 1997 |
| * | K990810 | Arglaes-AB Antimicrobial Barrier Film Dressing & Island DressingSummary page 2…ilver Alginate Foam Dressing (KOI 1618) 2. ARGLAES-ABTM Antimicrobial Barrier Film Dressing (K970566) 3. ARGLAES-AB TM Antimicrobial Barrier Film Dressing (K990810) The device is a silver ion-containing dressing in which the silver ion is in the-form of a molecule of silver algi… | 1999 |
What descends from it? (2)
2 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?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 5.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K173072 (Deroyal Industries, Inc., 2018) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K011618.
How does its category compare?
All MGQ devicesMGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MGQ
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MGQ
Too few MGQ 510(k)s in any year since 2007 to give a median.
Recalls per year · MGQ
4in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MGQ
5in 2025
MAUDE reports naming product code MGQ, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 4 | 10 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 11 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Pressure ulccrs,.Stages I-IV
Dermal lesions (or secreting skin injuries)
Venous ulcers, Staiis ulcers
Intended to protect vascular access sites,
intramuscular sites. and surgical incisions
1" and 2t degree bums
Donor sites
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041268 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041268: Silversite or Calgitrol.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041268
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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