510(k) · Cleared
ClearedHydroMID 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)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Access Vascular, Inc. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Mar 27, 2025 as substantially equivalent to K220772 (Access Vascular, Inc., 2022) after an 86-day review. Its family tree reaches back 11 generations to 1993.
- Decided
- Mar 27, 2025
- Review
- 86 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K932323 (1993). 26 ancestors in all, the oldest K801941 (1980). No later device cites it as a predicate yet.
- Root · 11 generations backK932323 Percutaneous IntroducerMedamicus, Inc. · 1993
- 7 generations between
- 3 generations backK150407 BioFlo Midline CatheterNavilyst Medical, Inc. · 2015
- 2 generations backK203069 HydroMIDAccess Vascular, Inc. · 2021 · Recalled
- 1 generation backK220772 HydroMID 4F Single Lumen Midline CatheterAccess Vascular, Inc. · 2022
- This deviceK244059 HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102)…Access Vascular, Inc. · 2025
Show all 11 generations
- Root · 11 generations backK932323 Percutaneous IntroducerMedamicus, Inc. · 1993
- 10 generations backK990705 Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific…Medamicus, Inc. · 1999 · Recalled
- 9 generations backK071574 Stiffer Coaxial Micro-Introducer KitEnpath Medical, Inc. · 2007 · Recalled
- 8 generations backK090372 The Wand Microaccess Safety IntroducerAccess Scientific, Inc. · 2009
- 7 generations backK093022 The Picc Wand Peelable Safety IntroducerAccess Scientific, Inc. · 2010
- 6 generations backK101422 The Power Wand Safety Introducer with an Extended Dwell CatheterAccess Scientific, Inc. · 2011
- 5 generations backK121073 Powerglide Midline CatheterC.R. Bard, Inc. · 2012 · Recalled
- 4 generations backK133856 Powerglide Midline CatheterC.R. Bard, Inc. · 2014 · Recalled
- 3 generations backK150407 BioFlo Midline CatheterNavilyst Medical, Inc. · 2015
- 2 generations backK203069 HydroMIDAccess Vascular, Inc. · 2021 · Recalled
- 1 generation backK220772 HydroMID 4F Single Lumen Midline CatheterAccess Vascular, Inc. · 2022
- This deviceK244059 HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102)…Access Vascular, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K932323 | Percutaneous Introducer | Medamicus, Inc. | 1993 | — |
| −10 | K990705 | Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific Coaxial Dilator… | Medamicus, Inc. | 1999 | 1 |
| −9 | K071574 | Stiffer Coaxial Micro-Introducer Kit | Enpath Medical, Inc. | 2007 | 2 |
| −8 | K090372 | The Wand Microaccess Safety Introducer | Access Scientific, Inc. | 2009 | — |
| −7 | K093022 | The Picc Wand Peelable Safety Introducer | Access Scientific, Inc. | 2010 | — |
| −6 | K101422 | The Power Wand Safety Introducer with an Extended Dwell Catheter | Access Scientific, Inc. | 2011 | — |
| −5 | K121073 | Powerglide Midline Catheter | C.R. Bard, Inc. | 2012 | 1 |
| −4 | K133856 | Powerglide Midline Catheter | C.R. Bard, Inc. | 2014 | 1 |
| −3 | K150407 | BioFlo Midline Catheter | Navilyst Medical, Inc. | 2015 | — |
| −2 | K203069 | HydroMID | Access Vascular, Inc. | 2021 | 3 |
| −1 | K220772 | HydroMID 4F Single Lumen Midline Catheter | Access Vascular, Inc. | 2022 | — |
| 0 (this device) | K244059 | HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F… | Access Vascular, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 2008 | 2 | 0 |
| 2011 | 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 FOZ? 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 FOZ device
- #1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K220772 | HydroMID 4F Single Lumen Midline CatheterSummary page 6…6 Predicate Device(s) The predicate device is the HydroMID Product Family of Midline Catheters, which was previously cleared under premarket application K220772. Reference Device(s) The reference device is the HydroPICC-251 5F Dual Lumen, which was previously cleared under premarket applic… | 2022 |
| † | K213550 | HydroPICC 5F Dual Lumen Catheter | 2022 |
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 32 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 10 of the 26 ancestors have a recall of any class.
- 1 other device also cites its predicate K220772.
How does its category compare?
All FOZ devicesFOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · FOZ
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FOZ
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FOZ
4in 2023
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · FOZ
5,110in 2025
MAUDE reports naming product code FOZ, 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 | 6 | 159 | 16 | 374 |
| 2008 | 9 | 103 | 0 | 422 |
| 2009 | 9 | 30 | 23 | 508 |
| 2010 | 3 | 28 | 115 | 370 |
| 2011 | 6 | 132 | 0 | 786 |
| 2012 | 13 | 122 | 0 | 560 |
| 2013 | 4 | 104 | 2 | 640 |
| 2014 | 9 | 99 | 4 | 815 |
| 2015 | 10 | 107 | 0 | 729 |
| 2016 | 9 | 63 | 3 (1) | 925 |
| 2017 | 9 | 51 | 22 | 1,966 |
| 2018 | 1 | — | 4 | 3,305 |
| 2019 | 8 | 140 | 3 | 4,365 |
| 2020 | 10 | 191 | 3 | 3,797 |
| 2021 | 4 | 242 | 1 | 4,674 |
| 2022 | 8 | 183 | 4 (2) | 4,133 |
| 2023 | 9 | 129 | 4 (2) | 4,430 |
| 2024 | 6 | 190 | 0 | 4,772 |
| 2025 | 11 | 91 | 0 | 5,110 |
| 2026 | 7 | 203 | 2 | — |
What is it indicated for?
The HydroMID 5F Dual Lumen Midline Catheter is indicated for short term access (< 30 days) 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.
Rated for maximum power injection flow rate of 6ml/s.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K244059 · printed Nov 6, 2026
Cite this page
510(k) Report. “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).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K244059
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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