510(k) · Cleared
ClearedHydrocolloid Wound Dressings
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovative Technologies, Ltd. · FRO Dressing, Wound, Drug
Cleared on Jun 24, 1997 after an 89-day review. The FDA summary names its predicate without a number. 11 later devices descend from it.
- Decided
- Jun 24, 1997
- Review
- 89 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 3 citing it directly.
- This deviceK971126 Hydrocolloid Wound DressingsInnovative Technologies, Ltd. · 1997
- Descendant · cites it directly · 5 of its ownK973855 IT Hydrocolloid with ZincInnovative Technologies, Ltd. · 1997
- Descendant · 2 generations on · 4 of its ownK060237 CMB Antimicrobial DressingSilverleaf Medical Products, Inc. · 2006
- Descendant · 3 generations on · 3 of its ownK081977 Prosit Wound Treatment DeviceSilverleaf Medical Products, Inc. · 2008
- Descendant · cites it directly · 3 of its ownK983303 Innovative Technologies Hydrocolloid and Intelligent Hydrocolloid…Innovative Technologies, Ltd. · 1998
- Descendant · 3 generations on · 2 of its ownK130350 ProcelleraVomaris Innovations, Inc. · 2013
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K973855IT Hydrocolloid with ZincInnovative Technologies, Ltd. · 1997 · cites it directly5descendants
- K060237CMB Antimicrobial DressingSilverleaf Medical Products, Inc. · 2006 · 2 generations on4descendants
- K081977Prosit Wound Treatment DeviceSilverleaf Medical Products, Inc. · 2008 · 3 generations on3descendants
- K983303Innovative Technologies Hydrocolloid and Intelligent Hydrocolloid Wound DressingsInnovative Technologies, Ltd. · 1998 · cites it directly3descendants
- K130350ProcelleraVomaris Innovations, Inc. · 2013 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971126 | Hydrocolloid Wound Dressings | Innovative Technologies, Ltd. | 1997 | — |
| +1 | K973855 | IT Hydrocolloid with Zinc | Innovative Technologies, Ltd. | 1997 | — |
| +2 | K060237 | CMB Antimicrobial Dressing | Silverleaf Medical Products, Inc. | 2006 | — |
| +3 | K081977 | Prosit Wound Treatment Device | Silverleaf Medical Products, Inc. | 2008 | — |
| +1 | K983303 | Innovative Technologies Hydrocolloid and Intelligent Hydrocolloid Wound… | Innovative Technologies, Ltd. | 1998 | — |
| +3 | K130350 | Procellera | Vomaris Innovations, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 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 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? (1)
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 |
|---|---|---|---|
| * | — | Duoderm CGF / Extra Thin Hydrocolloid Dressings Named without a submission number |
What descends from it? (11)
See all 113 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, K973855 (Innovative Technologies, Ltd., 1997) has gone furthest, with 5 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?
Innovative Technologies' Hydrocolloid & Intelligent Hydrocolloid Wound Dressings may be used for the management of wounds including:
Partial - full thickness wounds, i.e. arterial/venous, diabetic ulcers
Post-operative surgical wounds
Donor Sites
Trauma Wounds
Dermal Lesions
Protective dressing
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/K971126 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971126: Hydrocolloid Wound Dressings.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971126
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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