510(k) · Cleared
ClearedIT Hydrocolloid with Zinc
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 Dec 1, 1997 as substantially equivalent to K951499 (Derma Sciences, Inc., 1995) and 1 other predicate after a 53-day review. Its family tree reaches back 1 generation to 1995. 5 later devices descend from it.
- Decided
- Dec 1, 1997
- Review
- 53 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K951499 (1995). 2 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK951499 Dermagran Hydrophilic OintmentDerma Sciences, Inc. · 1995
- This deviceK973855 IT Hydrocolloid with ZincInnovative Technologies, Ltd. · 1997
- Descendant · cites it directly · 4 of its ownK060237 CMB Antimicrobial DressingSilverleaf Medical Products, Inc. · 2006
- Descendant · 2 generations on · 3 of its ownK081977 Prosit Wound Treatment DeviceSilverleaf Medical Products, Inc. · 2008
- Descendant · 2 generations on · 2 of its ownK130350 ProcelleraVomaris Innovations, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK160783 ProcelleraVomaris Innovations, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK180533 Procellera Composite Antibacterial Wound DressingVomaris Wound Care, Inc. · 2018
Most influential descendants
Showing 5 of 5 · See all- K060237CMB Antimicrobial DressingSilverleaf Medical Products, Inc. · 2006 · cites it directly4descendants
- K081977Prosit Wound Treatment DeviceSilverleaf Medical Products, Inc. · 2008 · 2 generations on3descendants
- K130350ProcelleraVomaris Innovations, Inc. · 2013 · 2 generations on2descendants
- K160783ProcelleraVomaris Innovations, Inc. · 2016 · 2 generations on1descendant
- K180533Procellera Composite Antibacterial Wound DressingVomaris Wound Care, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951499 | Dermagran Hydrophilic Ointment | Derma Sciences, Inc. | 1995 | — |
| 0 (this device) | K973855 | IT Hydrocolloid with Zinc | Innovative Technologies, Ltd. | 1997 | — |
| +1 | K060237 | CMB Antimicrobial Dressing | Silverleaf Medical Products, Inc. | 2006 | — |
| +2 | K081977 | Prosit Wound Treatment Device | Silverleaf Medical Products, Inc. | 2008 | — |
| +2 | K130350 | Procellera | Vomaris Innovations, Inc. | 2013 | — |
| +2 | K160783 | Procellera | Vomaris Innovations, Inc. | 2016 | — |
| +2 | K180533 | Procellera Composite Antibacterial Wound Dressing | Vomaris Wound Care, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 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? (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 |
|---|---|---|---|
| * | K951499 | Dermagran Hydrophilic OintmentSummary page 1…rector of QA/RA Monday, October 6, 1997 Innovative Technologies' Hydrocolloid with Zinc Wound Dressings is a combination of two products with existing 510(k)s: 510(k) #K951499, Dermagran-B™ Hydrophilic Wound Dressing manufactured by Derma Sciences, and 510(k) #K971126, Innovative Technologies' Hydrocoll… | 1995 |
| * | K971126 | Hydrocolloid Wound DressingsSummary page 1…Dressings is a combination of two products with existing 510(k)s: 510(k) #K951499, Dermagran-B™ Hydrophilic Wound Dressing manufactured by Derma Sciences, and 510(k) #K971126, Innovative Technologies' Hydrocolloid & Intelligent Hydrocolloid Wound Dressing. DEC ~ | 1997 Innovative Technologies' Hydroco… | 1997 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060237 | CMB Antimicrobial Dressing | 2006 | 4 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K060237 (Silverleaf Medical Products, Inc., 2006) has gone furthest, with 4 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 with Zinc Wound Dressings may be used for the management
of wounds including:
Partial - full thickness wounds, ie. arterial, venous, diabetic ulcers
Post-operative surgical wounds
Superficial burns (1st & 2nd degree)
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/K973855 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973855: IT Hydrocolloid with Zinc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973855
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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