510(k) · Cleared
ClearedVygon PICCs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vygon USA · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Feb 26, 2018 as substantially equivalent to K051672 (Bard Access Systems, Inc., 2005) after a 157-day review. Its family tree reaches back 6 generations to 2000. 2 later devices descend from it.
- Decided
- Feb 26, 2018
- Review
- 157 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K001901 (2000). 7 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 5 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 4 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 3 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 2 generations backK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
- 1 generation backK051672 PowerpiccBard Access Systems, Inc. · 2005 · Recalled
- This deviceK172899 Vygon PICCsVygon USA · 2018
- Descendant · cites it directly · 1 of its ownK191195 PiccGuardPiccguard, LLC · 2020
- Descendant · 2 generations on · 0 of its ownK220507 3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large3M Company · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −5 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −4 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −3 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −2 | K050931 | 6 FR DL Powerpicc Catheter | C.R. Bard, Inc. | 2005 | — |
| −1 | K051672 | Powerpicc | Bard Access Systems, Inc. | 2005 | 1 |
| 0 (this device) | K172899 | Vygon PICCs | Vygon USA | 2018 | — |
| +1 | K191195 | PiccGuard | Piccguard, LLC | 2020 | — |
| +2 | K220507 | 3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large | 3M Company | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 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.
Planning a device in LJS? 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 LJS device
- #1 K241910 Neonav ECG Tip Location Systemscore 18.0 · 12 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 |
|---|---|---|---|
| * | K051672 | PowerpiccSummary page 4…Classification Name: LJS - Percutaneous, Implanted, Long-Term Intravascular Catheter Premarket Notification: K051672 Manufacturer: Bard Access Systems, Inc. Per the FDA Medical Device Recalls Database, this predicate… | 2005 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191195 | PiccGuard | 2020 | 1 |
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 18 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- 4 of the 7 ancestors have a recall of any class.
- Of its descendants, K191195 (Piccguard, LLC, 2020) has gone furthest, with 1 descendant of its own.
- 8 other devices also cite its predicate K051672.
How does its category compare?
All LJS devicesLJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · LJS
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LJS
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LJS
5in 2023
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · LJS
4,372in 2025
MAUDE reports naming product code LJS, 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 | 14 | 92 | 0 | 392 |
| 2008 | 4 | 97 | 1 | 369 |
| 2009 | 16 | 70 | 1 | 379 |
| 2010 | 9 | 114 | 12 | 495 |
| 2011 | 6 | 55 | 4 | 696 |
| 2012 | 14 | 77 | 40 | 564 |
| 2013 | 14 | 31 | 0 | 680 |
| 2014 | 8 | 47 | 15 | 842 |
| 2015 | 7 | 71 | 2 | 1,306 |
| 2016 | 9 | 128 | 18 | 1,123 |
| 2017 | 7 | 101 | 9 | 2,100 |
| 2018 | 10 | 148 | 3 | 2,324 |
| 2019 | 0 | — | 0 | 2,052 |
| 2020 | 2 | — | 0 | 2,539 |
| 2021 | 3 | 284 | 1 | 3,084 |
| 2022 | 3 | 177 | 0 | 3,256 |
| 2023 | 4 | 47 | 5 (2) | 2,799 |
| 2024 | 1 | — | 0 | 4,243 |
| 2025 | 8 | 171 | 0 | 4,372 |
| 2026 | 2 | — | 8 (1) | — |
What is it indicated for?
The catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, power injection of contrast media, and allow(s) for central venous pressure monitoring. For blood sampling, infusion or therapy, use 4 French or larger catheter. The maximum recommended infusion rate is 5mL/sec for power injection of contrast media. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172899 · printed Nov 5, 2026
Cite this page
510(k) Report. “K172899: Vygon PICCs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K172899
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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