510(k) · Cleared
ClearedOxyband Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oxyband Technologies, Inc. · NAD Dressing, Wound, Occlusive
Cleared on Mar 24, 2005 as substantially equivalent to K973036 (3M Healthcare, 1997) and 2 other predicates after a 139-day review. Its family tree reaches back 4 generations to 1981.
- Decided
- Mar 24, 2005
- Review
- 139 days
- Class
- Class I
- Product code
- NAD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K811291 (1981). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK811291 Tegaderm Transparent Dressing3M Company · 1981
- 3 generations backK961319 EpiviewConvatec, A Division of E.R. Squibb & Sons · 1996
- 2 generations backK991214 Simplicare Transparent Wound DressingHollister, Inc. · 1999
- 1 generation backK020781 Wet ChamberKinetic Concepts, Inc. · 2002
- This deviceK043063 Oxyband Wound DressingOxyband Technologies, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K811291 | Tegaderm Transparent Dressing | 3M Company | 1981 | — |
| −3 | K961319 | Epiview | Convatec, A Division of E.R. Squibb & Sons | 1996 | — |
| −2 | K991214 | Simplicare Transparent Wound Dressing | Hollister, Inc. | 1999 | — |
| −1 | K020781 | Wet Chamber | Kinetic Concepts, Inc. | 2002 | — |
| 0 (this device) | K043063 | Oxyband Wound Dressing | Oxyband Technologies, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 2 | 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 NAD? 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 NAD device
- #1 K254246 LT Antibacterial Foam with Silver Dressingscore 13.5 · 6 generations · no Class I recall
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K973036 | 3M Tegaderm Transparent Dressing, 3M Tegaderm Transparent Dressing (First Aid Delivery)…Summary page 1…Devices 3. Predicate Devices The OxyBand TM Wound Dressing is substantially equivalent to the 3M Medical Products Tegaderm TM Transparent Dressing (K973036), the Innovative Technologies, Ltd. Transparent Film and Intelligent Film Dressings (K973312) and the Kinetic Conce… | 1997 |
| * | K973312 | Transparent Film Dressing, Intelligent Film DressingSummary page 1…t to the 3M Medical Products Tegaderm TM Transparent Dressing (K973036), the Innovative Technologies, Ltd. Transparent Film and Intelligent Film Dressings (K973312) and the Kinetic Concepts, Inc. KCI Wound Cell Transparent Wound Dressing (K020781). 4. Device Description… | 1997 |
| * | K020781 | Wet ChamberSummary page 1…Technologies, Ltd. Transparent Film and Intelligent Film Dressings (K973312) and the Kinetic Concepts, Inc. KCI Wound Cell Transparent Wound Dressing (K020781). 4. Device Description OxyBand'TM is a multilayer wound dressing that keeps out water, dirt and germs, and su… | 2002 |
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.
What does this lineage say?
- The line of descent spans 24 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- None of the 8 ancestors has a recall.
- 7 other devices also cite its predicate K973036.
How does its category compare?
All NAD devicesNAD Dressing, Wound, Occlusive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NAD
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · NAD
Too few NAD 510(k)s in any year since 2007 to give a median.
Recalls per year · NAD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NAD
2,619in 2025
MAUDE reports naming product code NAD, 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 | 2 | — | 0 | 8 |
| 2009 | 1 | — | 0 | 9 |
| 2010 | 0 | — | 1 | 30 |
| 2011 | 1 | — | 0 | 9 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 15 |
| 2014 | 0 | — | 1 | 63 |
| 2015 | 0 | — | 0 | 251 |
| 2016 | 0 | — | 0 | 106 |
| 2017 | 0 | — | 0 | 134 |
| 2018 | 0 | — | 6 | 1,029 |
| 2019 | 0 | — | 0 | 588 |
| 2020 | 0 | — | 0 | 5,035 |
| 2021 | 0 | — | 0 | 451 |
| 2022 | 0 | — | 1 | 403 |
| 2023 | 0 | — | 0 | 1,619 |
| 2024 | 0 | — | 0 | 1,804 |
| 2025 | 0 | — | 1 | 2,619 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
OxyBand TM Wound Dressings are intended to provide a moist environment to facilitate the normal wound healing process. OxyBand TM Wound Dressings can be used to cover and protect wounds and catheter sites, or used as a secondary dressing for other wound products such as gauze, alginates, hydrogels, debridement facilitators, or a protective cover over at risk skin. The OxyBand TM Wound Dressings are indicated for: clean closed surgical incisions, skin…
Read the full statement (312 words)
OxyBand TM Wound Dressings are intended to provide a moist environment to facilitate the normal wound healing process. OxyBand TM Wound Dressings can be used to cover and protect wounds and catheter sites, or used as a secondary dressing for other wound products such as gauze, alginates, hydrogels, debridement facilitators, or a protective cover over at risk skin. The OxyBand TM Wound Dressings are indicated for: clean closed surgical incisions, skin graft donor sites, Stage I or I1 pressure ulcers, pressure sores, superficial wounds such as abrasions, skin tears, and blisters, lacerations, first and second degree burns, chafed skin, skin continuously exposed to moisture, secondary dressing over gauze, alginates or hydrogels.
OxyBand TM Wound Dressings are intended to protect light to moderate wounds, including skin tears, scrapes, minor pressure sores, abrasions, blisters, lacerations, minor bums, to protect chafed or irritated skin or skin continuously exposed to moisture, and to create a moist environment for wound healing.
OxyBand TM Wound Dressings are intended to provide a moist environment to facilitate the normal wound healing process. OxyBand TM Wound Dressings can be used to cover and protect wounds and catheter sites, or used as a secondary dressing for other wound products such as gauze, alginates, hydrogels, debridement facilitators, or a protective cover over at risk skin. The OxyBand TM Wound Dressings are indicated for: clean closed surgical incisions, skin graft donor sites, Stage I or I1 pressure ulcers, pressure sores, superficial wounds such as abrasions, skin tears, and blisters, lacerations, first and second degree burns, chafed skin, skin continuously exposed to moisture, secondary dressing over gauze, alginates or hydrogels.
OxyBand TM Wound Dressings are intended to protect light to moderate wounds, including skin tears, scrapes, minor pressure sores, abrasions, blisters, lacerations, minor bums, to protect chafed or irritated skin or skin continuously exposed to moisture, and to create a moist environment for wound healing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043063 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043063: Oxyband Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043063
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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