510(k) · Cleared
ClearedInnovative Technologies Hydrocolloid and Intelligent Hydrocolloid Wound Dressings
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovative Technologies, Ltd. · MGP Dressing, Wound And Burn, Occlusive
Cleared on Dec 9, 1998 as substantially equivalent to K971126 (Innovative Technologies, Ltd., 1997) after a 79-day review. Its family tree reaches back 1 generation to 1997. 3 later devices descend from it.
- Decided
- Dec 9, 1998
- Review
- 79 days
- Class
- Class U
- Product code
- MGP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K971126 (1997). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK971126 Hydrocolloid Wound DressingsInnovative Technologies, Ltd. · 1997
- This deviceK983303 Innovative Technologies Hydrocolloid and Intelligent Hydrocolloid…Innovative Technologies, Ltd. · 1998
- Descendant · cites it directly · 2 of its ownK033900 X-Static Silverseal Hydrocolloid Film and Island DressingNoble Fiber Technologies · 2005
- Descendant · 2 generations on · 1 of its ownK072378 Prowick Antimicrobial Postoperative Wound Dressing, Shoulder and…Arthrex, Inc. · 2007
- Descendant · 3 generations on · 0 of its ownK083007 ProwickArthrex, Inc. · 2009
Most influential descendants
Showing 3 of 3 · See all- K033900X-Static Silverseal Hydrocolloid Film and Island DressingNoble Fiber Technologies · 2005 · cites it directly2descendants
- K072378Prowick Antimicrobial Postoperative Wound Dressing, Shoulder and Knee, Models AR-1625…Arthrex, Inc. · 2007 · 2 generations on1descendant
- K083007ProwickArthrex, Inc. · 2009 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971126 | Hydrocolloid Wound Dressings | Innovative Technologies, Ltd. | 1997 | — |
| 0 (this device) | K983303 | Innovative Technologies Hydrocolloid and Intelligent Hydrocolloid Wound… | Innovative Technologies, Ltd. | 1998 | — |
| +1 | K033900 | X-Static Silverseal Hydrocolloid Film and Island Dressing | Noble Fiber Technologies | 2005 | — |
| +2 | K072378 | Prowick Antimicrobial Postoperative Wound Dressing, Shoulder and Knee, Models… | Arthrex, Inc. | 2007 | — |
| +3 | K083007 | Prowick | Arthrex, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 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 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? (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 |
|---|---|---|---|
| * | K971126 | Hydrocolloid Wound Dressings Our OCR of the scanned summary read K071126, FDA’s number for Cryoseal FS Applicator System (Thermogenesis Corp.), decided Aug 16, 2007, after this device. Corrected to the only number one digit away that is an earlier device of this one’s maker, Innovative Technologies, Ltd., in this field. | 1997 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033900 | X-Static Silverseal Hydrocolloid Film and Island Dressing | 2005 | 2 |
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?
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?
Innovative Technologies Hydrocolloid & Intelligent Hydrocolloid Wound Dressings may be used for the management of wounds including: Minor Scalds and Minor Burns Superficial Wounds such as abrasions, lacerations and minor cuts Protective dressing for uses such as minor blisters This wound dressing may also be used under the care of a health care professional for such wounds as Partial - full thickness wounds i.e. Arterial Ulcers, Venous ulcers, and diabetic ulcers, post operative surgical wounds and donor sites.
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/K983303 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983303: Innovative Technologies Hydrocolloid and Intelligent 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/K983303
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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