510(k) · Cleared
ClearedLeaderflex Mini and Leaderflex Nano
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vygon USA · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Aug 29, 2022 as substantially equivalent to K141026 (Vygon, 2014) after a 395-day review. Its family tree reaches back 8 generations to 1993.
- Decided
- Aug 29, 2022
- Review
- 395 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K932323 (1993). 25 ancestors in all, the oldest K801941 (1980). No later device cites it as a predicate yet.
- 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 backK141026 LeaderflexVygon · 2014
- This deviceK212370 Leaderflex Mini and Leaderflex NanoVygon USA · 2022
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 | K141026 | Leaderflex | Vygon | 2014 | — |
| 0 (this device) | K212370 | Leaderflex Mini and Leaderflex Nano | Vygon USA | 2022 | — |
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 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 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 |
|---|---|---|---|
| * | K141026 | LeaderflexSummary page 4…ascular Catheter Classification Class II Regulation 21 CFR 880.5200 – Intravascular catheter 5.6. Predicate Device: Leaderflex (K141026) 5.7. Submission Purpose: The purpose of this 510(k) submission is to implement design changes to the predicate Leader… | 2014 |
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 29 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- 9 of the 25 ancestors have a recall of any class.
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. 2022, 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?
Leaderfiex mini and Leaderfiex nano are indicated for:
*Peripheral venous catheterization (midline) in any patient population with consideration given to the adequacy of vascular anatomy and appropriateness of procedure, or
*Arterial catheterization
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212370 · printed Nov 5, 2026
Cite this page
510(k) Report. “K212370: Leaderflex Mini and Leaderflex Nano.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K212370
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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