510(k) · Cleared
Recalled · Class II · 2019Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vygon USA · PND Midline Catheter
Cleared on Nov 2, 2018 as substantially equivalent to K153393 (C.R. Bard, Inc., 2016) after a 179-day review. Its family tree reaches back 11 generations to 2000. 2 of the 29 devices in its family, counting itself, have a Class I recall. It has been recalled once.
- Decided
- Nov 2, 2018
- Review
- 179 days
- Class
- Class II
- Product code
- PND
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 11 generations to K001901 (2000). 28 ancestors in all, the oldest K830256 (1983). No later device cites it as a predicate yet. 2 of the 29 devices in this family, counting this one, have a Class I recall.
- Root · 11 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 7 generations between
- 3 generations backK091953 Pro-PiccMedcomp · 2009
- 2 generations backK141151 CT MidlineMedcomp (Medical Components, Inc.) · 2014
- 1 generation backK153393 PowerMidline CatheterC.R. Bard, Inc. · 2016 · Recalled
- This deviceK181208 Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter…Vygon USA · 2018
Show all 11 generations
- Root · 11 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 10 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 9 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 8 generations backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
- 7 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
- 6 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
- 5 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- 4 generations backK070996 4 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc. · 2007
- 3 generations backK091953 Pro-PiccMedcomp · 2009
- 2 generations backK141151 CT MidlineMedcomp (Medical Components, Inc.) · 2014
- 1 generation backK153393 PowerMidline CatheterC.R. Bard, Inc. · 2016 · Recalled
- This deviceK181208 Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter…Vygon USA · 2018
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −10 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −9 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −8 | K033389 | Powerpicc Catheters, Models 3175155, 3175135 | C.R. Bard, Inc. | 2004 | 1 |
| −7 | K050185 | Powerhohn and Powerline Catheters | C.R. Bard, Inc. | 2005 | — |
| −6 | K051417 | 6 FR FL Powerhohn and Powerline Catheter | C.R. Bard, Inc. | 2005 | 1 |
| −5 | K051991 | Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line | C.R. Bard, Inc. | 2005 | — |
| −4 | K070996 | 4 FR Single Lumen (SL) Powerpicc Catheter | C.R. Bard, Inc. | 2007 | — |
| −3 | K091953 | Pro-Picc | Medcomp | 2009 | — |
| −2 | K141151 | CT Midline | Medcomp (Medical Components, Inc.) | 2014 | — |
| −1 | K153393 | PowerMidline Catheter | C.R. Bard, Inc. | 2016 | 1 |
| 0 (this device) | K181208 | Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline… | Vygon USA | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 1 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 1 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 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.
2 devices in this family have a Class I recall. 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 PND device
- #1 K252402 Midline Catheterscore 13.2 · 10 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 |
|---|---|---|---|
| * | K153393 | PowerMidline CatheterSummary page 4…dline™ Catheter Common/Usual Name: Midline Catheter Classification Name: PND – Intravascular Catheter Premarket Notification: K153393 Manufacturer: Bard Access Systems, Inc. Per the FDA Medical Device Recalls Database, this predicate… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 24, 2019 | Class II | Z-0585-2020 | Packaging process control | Potential that 3Fr size catheter placed in the catheter tray instead of 4Fr for the 4Fr x 20cm Single Lumen CT Midline Basic Tray. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K993691Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 2000 · 7 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K862056[Central Venous][Multi-Lumen] Catheter W/Flex TipArrow Intl., Inc. · 1986 · 8 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 13 of the 28 ancestors have a recall of any class; 2 have a Class I recall.
- 2 other devices also cite its predicate K153393.
How does its category compare?
All PND devicesPND Midline Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · PND
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PND
134in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PND
4so far in 2026, the most since 2007
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · PND
141in 2025
MAUDE reports naming product code PND, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 3 | 106 | 0 | 5 |
| 2017 | 3 | 134 | 0 | 23 |
| 2018 | 2 | — | 0 | 19 |
| 2019 | 1 | — | 1 | 59 |
| 2020 | 0 | — | 2 | 93 |
| 2021 | 1 | — | 0 | 86 |
| 2022 | 2 | — | 1 | 178 |
| 2023 | 0 | — | 0 | 138 |
| 2024 | 0 | — | 0 | 168 |
| 2025 | 1 | — | 0 | 141 |
| 2026 | 0 | — | 4 (1) | — |
What is it indicated for?
The catheters are indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The catheters are suitable for use with power injectors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181208 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181208: Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181208
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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