IV Securement Devices
FDA 510(k) K854464 · Avery Intl.
510(k) numberK854464
Submission
- Device name
- IV Securement Devices
- Applicant
- Avery Intl.
Painesville, OH, US - Received
- November 6, 1985
- Decision date
- March 3, 1986
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- FRO – Dressing, Wound, Drug
- Device class
- Unclassified
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|---|---|---|---|
| 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 |
|---|---|---|
| K870093 | Medical Adhesive Tape & Bandage Using Pcce FilmKGX · Traditional | 02/05/1987SN |
| K870092 | Medical Adhesive Tape & Bandage Using Hytrel FilmKGX · Traditional | 02/05/1987SN |
| K870021 | Medical Adhesive Tape and Adhesive BandageKGX · Traditional | 02/05/1987SN |
| K870124 | Surgical Drapes and Accessories Using Pebax FilmKKX · Traditional | 02/04/1987SE |
| K870123 | Surgical Drapes and Accessories Using Pcce FilmKKX · Traditional | 02/04/1987SE |
| K870122 | Surgical Drapes and Accessories Using Hytrel FilmKKX · Traditional | 02/04/1987SE |
| K870091 | IV Securement Device Using Pcce Thermo. FilmKGX · Traditional | 02/04/1987SE |
| K870090 | IV Securement Device Using Hytrel Thermo. FilmKGX · Traditional | 02/04/1987SE |
| K870020 | IV Securement DeviceKGX · Traditional | 02/04/1987SE |
| K862438 | Surgical Drapes and Drape AccessoriesKKX · Traditional | 07/16/1986SN |
Questions and answers
When was IV Securement Devices cleared by the FDA?
IV Securement Devices (K854464) received a 510(k) decision of Substantially Equivalent for Some Indications on March 3, 1986, 117 days after the submission was received.
What is the product code of K854464?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.