510(k) · Cleared
ClearedBioFlo Midline Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Navilyst Medical, Inc. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on May 15, 2015 as substantially equivalent to K133856 (C.R. Bard, Inc., 2014) after an 86-day review. Its family tree reaches back 8 generations to 1993. 5 later devices descend from it.
- Decided
- May 15, 2015
- Review
- 86 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K932323 (1993). 23 ancestors in all, the oldest K801941 (1980). 5 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK932323 Percutaneous IntroducerMedamicus, Inc. · 1993
- 7 generations backK990705 Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific…Medamicus, Inc. · 1999 · Recalled
- 6 generations backK071574 Stiffer Coaxial Micro-Introducer KitEnpath Medical, Inc. · 2007 · Recalled
- 5 generations backK090372 The Wand Microaccess Safety IntroducerAccess Scientific, Inc. · 2009
- 4 generations backK093022 The Picc Wand Peelable Safety IntroducerAccess Scientific, Inc. · 2010
- 3 generations backK101422 The Power Wand Safety Introducer with an Extended Dwell CatheterAccess Scientific, Inc. · 2011
- 2 generations backK121073 Powerglide Midline CatheterC.R. Bard, Inc. · 2012 · Recalled
- 1 generation backK133856 Powerglide Midline CatheterC.R. Bard, Inc. · 2014 · Recalled
- This deviceK150407 BioFlo Midline CatheterNavilyst Medical, Inc. · 2015
- Descendant · cites it directly · 3 of its ownK203069 HydroMIDAccess Vascular, Inc. · 2021 · Recalled
- Descendant · 2 generations on · 2 of its ownK220772 HydroMID 4F Single Lumen Midline CatheterAccess Vascular, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK243458 HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic…Access Vascular, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK244059 HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102)…Access Vascular, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK161866 BioFlo Midline CatheterNavilyst Medical, Inc. · 2016 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K203069HydroMIDAccess Vascular, Inc. · 2021 · cites it directly3descendants
- K220772HydroMID 4F Single Lumen Midline CatheterAccess Vascular, Inc. · 2022 · 2 generations on2descendants
- K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301)…Access Vascular, Inc. · 2025 · 3 generations on0descendants
- K244059HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen…Access Vascular, Inc. · 2025 · 3 generations on0descendants
- K161866BioFlo Midline CatheterNavilyst Medical, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K932323 | Percutaneous Introducer | Medamicus, Inc. | 1993 | — |
| −7 | K990705 | Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific Coaxial Dilator… | Medamicus, Inc. | 1999 | 1 |
| −6 | K071574 | Stiffer Coaxial Micro-Introducer Kit | Enpath Medical, Inc. | 2007 | 2 |
| −5 | K090372 | The Wand Microaccess Safety Introducer | Access Scientific, Inc. | 2009 | — |
| −4 | K093022 | The Picc Wand Peelable Safety Introducer | Access Scientific, Inc. | 2010 | — |
| −3 | K101422 | The Power Wand Safety Introducer with an Extended Dwell Catheter | Access Scientific, Inc. | 2011 | — |
| −2 | K121073 | Powerglide Midline Catheter | C.R. Bard, Inc. | 2012 | 1 |
| −1 | K133856 | Powerglide Midline Catheter | C.R. Bard, Inc. | 2014 | 1 |
| 0 (this device) | K150407 | BioFlo Midline Catheter | Navilyst Medical, Inc. | 2015 | — |
| +1 | K203069 | HydroMID | Access Vascular, Inc. | 2021 | 3 |
| +2 | K220772 | HydroMID 4F Single Lumen Midline Catheter | Access Vascular, Inc. | 2022 | — |
| +3 | K243458 | HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit… | Access Vascular, Inc. | 2025 | — |
| +3 | K244059 | HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F… | Access Vascular, Inc. | 2025 | — |
| +1 | K161866 | BioFlo Midline Catheter | Navilyst Medical, Inc. | 2016 | 3 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K133856 | Powerglide Midline CatheterSummary page 4…FOZ / 880.5200 D. Predicate & Reference Devices Predicate 510(k): Trade Name: Bard PowerGlide Midline Catheter (K133856) Common/Usual Name: Midline Catheter Device Classification Name: I… | 2014 |
| † | K131942 | Nmi Picc Iii Catheter, Nmi Hpicc Iii Catheter | 2013 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 22 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 9 of the 23 ancestors have a recall of any class.
- Of its descendants, K203069 (Access Vascular, Inc., 2021) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K133856.
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. 2015, 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 BioFlo Midline is indicated for short term access (<30 days) to the peripheral venous 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 600 mOsm/L.
Maximum Power Injection Flow Rate:
-3F Single Lumen, 20 cm: 2 mI/sec
-4F Single Lumen, 20 cm: 6 mI/sec
-5F Single Lumen, 20 cm: 6 mL/sec
-5F Dual Lumen, 20 cm: 6 mL/scc
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K150407 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150407: BioFlo Midline Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150407
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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