510(k) · Cleared
ClearedTransparent Film Dressing, Intelligent Film Dressing
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 Oct 22, 1997 as substantially equivalent to K935796 (Wilshire Medical Products, 1994) after a 49-day review. Its family tree reaches back 1 generation to 1994. 4 later devices descend from it.
- Decided
- Oct 22, 1997
- Review
- 49 days
- Class
- Class U
- Product code
- MGP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K935796 (1994). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK935796 Hydroderm Breathable Transparent DressingWilshire Medical Products · 1994
- This deviceK973312 Transparent Film Dressing, Intelligent Film DressingInnovative Technologies, Ltd. · 1997
- Descendant · cites it directly · 3 of its ownK020781 Wet ChamberKinetic Concepts, Inc. · 2002
- Descendant · 2 generations on · 1 of its ownK060046 DermastreamEnzysurge, Ltd. · 2006
- Descendant · 2 generations on · 0 of its ownK091133 Aplion Topical Care SystemAplion Medical,Llc · 2009
- Descendant · cites it directly · 0 of its ownK043063 Oxyband Wound DressingOxyband Technologies, Inc. · 2005
Most influential descendants
Showing 4 of 4 · See all- K020781Wet ChamberKinetic Concepts, Inc. · 2002 · cites it directly3descendants
- K060046DermastreamEnzysurge, Ltd. · 2006 · 2 generations on1descendant
- K091133Aplion Topical Care SystemAplion Medical,Llc · 2009 · 2 generations on0descendants
- K043063Oxyband Wound DressingOxyband Technologies, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K935796 | Hydroderm Breathable Transparent Dressing | Wilshire Medical Products | 1994 | — |
| 0 (this device) | K973312 | Transparent Film Dressing, Intelligent Film Dressing | Innovative Technologies, Ltd. | 1997 | — |
| +1 | K020781 | Wet Chamber | Kinetic Concepts, Inc. | 2002 | — |
| +2 | K060046 | Dermastream | Enzysurge, Ltd. | 2006 | — |
| +2 | K091133 | Aplion Topical Care System | Aplion Medical,Llc | 2009 | — |
| +1 | K043063 | Oxyband Wound Dressing | Oxyband Technologies, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K935796 | Hydroderm Breathable Transparent Dressing Our OCR of the scanned summary read K335796, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Hydroderm Breathable Transparent Dressings”. | 1994 |
What descends from it? (4)
2 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?
- Its one ancestor has no recall.
- Of its descendants, K020781 (Kinetic Concepts, Inc., 2002) has gone furthest, with 3 descendants of its own.
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' Transparent Film and Intelligent Film Dressings are indicated for use on partial thickness wounds including:
Pressure sores
Superficial bums
Abrasions
Lacerations
Post-operative surgical wounds
Donor Sites
Trauma Wounds
Dermal Lesions
IV Sites
Figation-device
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/K973312 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973312: Transparent Film Dressing, Intelligent Film Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973312
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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