510(k) · Cleared
Recalled · Class II · 2026Groshong NXT PICC Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Mar 12, 2021 as substantially equivalent to K034020 (C.R. Bard, Inc., 2004) after a 284-day review. Its family tree reaches back 3 generations to 1991. It has been recalled 19 times.
- Decided
- Mar 12, 2021
- Review
- 284 days
- Class
- Class II
- Product code
- LJS
- Recalls
- 19
- Predicates
- 1
Its longest line of descent runs back 3 generations to K904558 (1991). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK904558 Dual Lumen 5 FR Perip Cent Ven Cath W/Groshong ValDavol, Inc. · 1991
- 2 generations backK023374 Groshong NXT Dual Lumen Picc CathetersC.R. Bard, Inc. · 2002 · Recalled
- 1 generation backK034020 Groshong NXT Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- This deviceK201452 Groshong NXT PICC CatheterC.R. Bard, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K904558 | Dual Lumen 5 FR Perip Cent Ven Cath W/Groshong Val | Davol, Inc. | 1991 | — |
| −2 | K023374 | Groshong NXT Dual Lumen Picc Catheters | C.R. Bard, Inc. | 2002 | 5 |
| −1 | K034020 | Groshong NXT Picc Catheters | C.R. Bard, Inc. | 2004 | 4 |
| 0 (this device) | K201452 | Groshong NXT PICC Catheter | C.R. Bard, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 |
|---|---|---|---|
| * | K034020 | Groshong NXT Picc CathetersSummary page 4…er: Bard Access Systems, Inc. (wholly owned subsidiary of BD) Premarket Notification: K034020 Common Name: Catheter, Intravascular, Therapeutic, Long-Term… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 21, 2026 | Class II | Z-2665-2026 | Nonconforming Material/Component | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. |
| Apr 7, 2021 | Class II | Z-1661-2021 | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the… |
| Apr 7, 2021 | Class II | Z-1653-2021 | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the… |
| Apr 7, 2021 | Class II | Z-1656-2021 | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the… |
| Apr 7, 2021 | Class II | Z-1668-2021 | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the… |
| Apr 7, 2021 | Class II | Z-1662-2021 | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the… |
| Apr 7, 2021 | Class II | Z-1659-2021 | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the… |
| Apr 7, 2021 | Class II | Z-1664-2021 | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the… |
| Apr 7, 2021 | Class II | Z-1657-2021 | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the… |
| Apr 7, 2021 | Class II | Z-1663-2021 | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the… |
| Apr 7, 2021 | Class II | Z-1660-2021 | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the… |
| Apr 7, 2021 | Class II | Z-1654-2021 | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the… |
| Apr 7, 2021 | Class II | Z-1665-2021 | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the… |
| Apr 7, 2021 | Class II | Z-1652-2021 | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the… |
| Apr 7, 2021 | Class II | Z-1669-2021 | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the… |
| Apr 7, 2021 | Class II | Z-1667-2021 | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the… |
| Apr 7, 2021 | Class II | Z-1655-2021 | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the… |
| Apr 7, 2021 | Class II | Z-1666-2021 | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the… |
| Apr 7, 2021 | Class II | Z-1658-2021 | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the… |
The 5 latest of 19 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 2 companies; a new generation was cleared every 11.8 years on median.
- 3 of the 4 ancestors have a recall of any class.
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. 2021, 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 Groshong® NXT PICC provides short (less than 30 days) or long (greater than 30 days) term peripheral access to the central venous system for intravenous therapy or blood sampling.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201452 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201452: Groshong NXT PICC Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201452
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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