510(k) · Cleared
ClearedCardiotech Antibotic Hydrogel Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiotech Intl. · MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Cleared on Dec 30, 2002 as substantially equivalent to K943314 (Johnson & Johnson Consumer Products, Inc., 1996) after a 147-day review. Its family tree reaches back 1 generation to 1996. 2 later devices descend from it.
- Decided
- Dec 30, 2002
- Review
- 147 days
- Class
- Class U
- Product code
- MGQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K943314 (1996). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK943314 Adhesive Bandages with Otc DrugJohnson & Johnson Consumer Products, Inc. · 1996
- This deviceK022584 Cardiotech Antibotic Hydrogel Wound DressingCardiotech Intl. · 2002
- Descendant · cites it directly · 1 of its ownK053476 AllwoundAt Squared, LLC · 2006
- Descendant · 2 generations on · 0 of its ownK211943 Microlyte Ag/LidocaineImbed Biosciences · 2024
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 |
|---|---|---|---|---|---|
| −1 | K943314 | Adhesive Bandages with Otc Drug | Johnson & Johnson Consumer Products, Inc. | 1996 | — |
| 0 (this device) | K022584 | Cardiotech Antibotic Hydrogel Wound Dressing | Cardiotech Intl. | 2002 | — |
| +1 | K053476 | Allwound | At Squared, LLC | 2006 | — |
| +2 | K211943 | Microlyte Ag/Lidocaine | Imbed Biosciences | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 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 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K830457 | FDA’s K830457 is Pacing Lead #Pma F 860 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1983 |
| * | K943314 | Adhesive Bandages with Otc DrugSummary page 1…to MEDLMAC Bandages (Enquay Pharmaceutical Associates, €330457)and Adhesive Bandage with Antiibiotk (Johnson & Johnson,K9433 14). Deseription: CardioTech Antiiiotic Hydrogel Wound Dressings are semiscclusive, an… | 1996 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053476 | Allwound | 2006 | 1 |
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 no recall.
- Of its descendants, K053476 (At Squared, LLC, 2006) has gone furthest, with 1 descendant of its own.
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?
CardioTech Antibiotic Hydrogel Wound Dressings are intended for use in the management of partial and full-thickness wounds. They may be used on the following wounds:
Venous stasis ulcers
Diabetic ulcers
Pressure sores
Blisters
Superficial burns
Abrasions and lacerations
Donor sites
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022584 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022584: Cardiotech Antibotic Hydrogel 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/K022584
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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