PROTOCOL Incision Dressing
FDA 510(k) K142962 · Deroyal Industries
510(k) numberK142962
Submission
- Device name
- PROTOCOL Incision Dressing
- Applicant
- Deroyal Industries
Powell, TN, US - Received
- October 14, 2014
- Decision date
- July 23, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRO – Dressing, Wound, Drug
- Device class
- Unclassified
Other 510(k)s with product code FRO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254041 | SkinSmart Antimicrobial HydroGelFRO · Traditional | Magic Science Supply, LLC | 09/11/2026SE |
| K261646 | Redermax® Antibacterial Wound MatrixFRO · Traditional | Beijing Kreate Medical Co., Ltd. | 08/14/2026SE |
| K253665 | Vashe Plus Antimicrobial SolutionFRO · Traditional | Urgo Medical North America, LLC | 08/11/2026SE |
| K261023 | Microdacyn Wound Irrigation SolutionFRO · Traditional | Sonoma Pharmaceuticals, Inc. | 06/24/2026SE |
| K251929 | SilverCeuticals® Antimicrobial Wound GelFRO · Traditional | Silverceuticals, Inc. | 06/24/2026SE |
| K261638 | Bonvadis®FRO · Special | Oneness Biotech Co., Ltd. | 06/17/2026SE |
| K254073 | StatSeal DiscFRO · Traditional | Merit Medical Systems, Inc. | 05/13/2026SE |
| K254191 | IWD-GelFRO · Traditional | InnovaCorium, Inc. | 04/07/2026SE |
| K252023 | MiraChlor Antimicrobial Wound SolutionFRO · Traditional | Letus Corporation | 03/25/2026SE |
| K251999 | Promogran Prisma Collagen Matrix with ORC and SilverFRO · Traditional | Solventum Germany GmbH | 03/13/2026SE |
More from Solventum Germany GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K250586 | Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam…OMP · Traditional | 11/21/2025SE |
| K230233 | Prospera Spectruum Negative Pressure Wound Therapy SystemOMP · Traditional | 04/18/2024SE |
| K200631 | DeRoyal Temperature Monitoring ProbeFLL · Traditional | 12/23/2020SE |
| K200757 | Foley Catheter with Temperature SensorEYC · Traditional | 10/15/2020SE |
| K200319 | HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface…FMT · Traditional | 04/02/2020SE |
| K193027 | Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal…BZT · Traditional | 04/02/2020SE |
| K191425 | Hydro-Temp Neonatal Skin Temperature Probe CoverFMT · Traditional | 01/21/2020SE |
| K173072 | Algidex Ag Silver Alginate Wound DressingFRO · Traditional | 04/04/2018SE |
| K171475 | DeRoyal Laprador Specimen Retrieval SystemGCJ · Traditional | 08/17/2017SE |
| K152978 | DeRoyal Angiography KitsDXT · Traditional | 03/25/2016SESK |
Questions and answers
When was PROTOCOL Incision Dressing cleared by the FDA?
PROTOCOL Incision Dressing (K142962) received a 510(k) decision of Substantially Equivalent on July 23, 2015, 282 days after the submission was received.
What is the product code of K142962?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.