# K203069: HydroMID

- Pathway: 510(k) (Abbreviated)
- Applicant: Access Vascular, Inc.
- Decided: Feb 8, 2021 after 122 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K932323 (1993). 24 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150407: BioFlo Midline Catheter, Navilyst Medical, Inc. (2015) Summary page 4.

## Most influential descendants
- K220772: HydroMID 4F Single Lumen Midline Catheter (2022), 2 descendants of its own
- K243458: HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); Hydr (2025), 0 descendants of its own
- K244059: HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104) (2025), 0 descendants of its own

## Recalls of this device
- Dec 22, 2022 · Class II · Z-1156-2023: Label with the incorrect component listed on the inner kit Tyvek header bag
- Dec 22, 2022 · Class II · Z-1155-2023: Product Mislabeled on the outer bag and inner kit Tyvek header bag
- Dec 16, 2022 · Class II · Z-1129-2023: Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.

## Indications for use
The HydroMID is indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy, including but not limited to, the administration of fluids, medications, and the sampling of blood and blood products. Therapies not appropriate for midline catheters include continuous vesicant therapy, parenteral nutrition, infusates with pH less than 5 or greater than 9, and infusates with an osmolarity greater than 600mOsm/L. HydroMID is rated for a Maximum Power Injection Flow Rate of 6mL/sec.

Source page: https://510kreport.com/device/K203069
Methodology: https://510kreport.com/methodology