510(k) · Cleared
ClearedSpyroflex Foam Island Wound Dressing, Spyroflex Foam Island Wound Dressing, Tinted, Spyrofoam
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovative Technologies (Us), Inc. · MGP Dressing, Wound And Burn, Occlusive
Cleared on Feb 6, 1998 after a 66-day review. The FDA summary names its predicate without a number.
- Decided
- Feb 6, 1998
- Review
- 66 days
- Class
- Class U
- Product code
- MGP
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 MGP? 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | SPYROFLEX Pigmented Wound Dressings Named without a submission number | |
| * | — | Tielle Hydropolymer Dressings Named without a submission number |
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.
How does its category compare?
All MGP devicesMGP Dressing, Wound And Burn, Occlusive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MGP
FDA has decided no MGP device since 2007.
Median 510(k) review, days · MGP
Too few MGP 510(k)s in any year since 2007 to give a median.
Recalls per year · MGP
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MGP
8in 2024
MAUDE reports naming product code MGP, 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 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 1 | 4 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 7 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 52 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
SPYROFLEX Foam Island Wound Dressings provide a degree of absorption and breathability. They are intended for use in the management of the following:
Venous stasis ulcers
Diabetic ulcers
Pressure sores
Donor sites
Blisters
Incisions
Severe sunbum
Poison Ivy
Partial-thickness wounds
Superficial burns
Abrasions and lacerations
Full-thickness wounds
Skin tears
Dermal lesions
Minor chemical burns
Thermal bumns
SPYROFLEX Foam Island Wound Dressings provide a degree of absorption and breathability. They are intended for use in the management of the following:
Abrasions
Superficial Blisters
Minor Burns
Superficial Cuts
Superficial Lacerations
Superficial Scrapes
Minor Rash
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974520 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974520: Spyroflex Foam Island Wound Dressing, Spyroflex Foam Island Wound Dressing, Tinted, Spyrofoam.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974520
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026