HydroMID
FDA 510(k) K203069 · Access Vascular, Inc.
510(k) numberK203069
Submission
- Device name
- HydroMID
- Applicant
- Access Vascular, Inc.
Bedford, MA, US - Received
- October 9, 2020
- Decision date
- February 8, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FOZ – Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5200
- Specialty
- General Hospital
Other 510(k)s with product code FOZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260432 | Ruby Intravascular CatheterFOZ · Traditional | Venocare, Inc. | 09/02/2026SE |
| K260165 | Unimpregnated Central Venous CatheterFOZ · Traditional | Spectrum Vascular | 08/10/2026SE |
| K261041 | ClearSafe Closed SystemFOZ · Traditional | MedSource Labs, LLC | 07/10/2026SE |
| K260539 | MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV CatheterFOZ · Traditional | MedSource Labs, LLC | 07/09/2026SE |
| K253235 | Introcan Safety® Deep Access XL IV CatheterFOZ · Traditional | B.Braun Medical, Inc. | 05/15/2026SE |
| K252137 | BD Insyte IV CatheterFOZ · Traditional | Becton Dickinson Infusion Therapy Systems, Inc. | 04/02/2026SE |
| K252513 | Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm…FOZ · Special | Poly Medicure Limited | 04/01/2026SE |
| K252398 | SURFLO Hybria Closed System Safety IV CatheterFOZ · Traditional | Terumo Medical Products (Hangzhou) Co., Ltd. | 12/17/2025SE |
| K252677 | Polyshield Safety IV CathetersFOZ · Special | Poly Medicure Limited | 11/05/2025SE |
| K251422 | BD Saf-T-Intima Subcutaneous Catheter SystemFOZ · Traditional | Becton Dickinson Infusion Therapy Systems, Inc. | 10/08/2025SE |
More from Becton Dickinson Infusion Therapy Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K243458 | HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301)…LJS · Traditional | 08/01/2025SE |
| K251212 | Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC…LJS · Special | 07/01/2025SE |
| K244059 | HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen…FOZ · Special | 03/27/2025SE |
| K243941 | HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201)…LJS · Special | 01/17/2025SE |
| K220772 | HydroMID 4F Single Lumen Midline CatheterFOZ · Traditional | 12/07/2022SE |
| K213550 | HydroPICC 5F Dual Lumen CatheterLJS · Traditional | 05/04/2022SE |
| K193015 | HydroPICC (PICC-142)LJS · Traditional | 02/20/2020SE |
| K172885 | HydroPICCLJS · Traditional | 02/20/2018SE |
Questions and answers
When was HydroMID cleared by the FDA?
HydroMID (K203069) received a 510(k) decision of Substantially Equivalent on February 8, 2021, 122 days after the submission was received.
What is the product code of K203069?
The FDA product code is FOZ – Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, a Class II (moderate risk) device regulated under 21 CFR 880.5200.