510(k) · Cleared
Recalled · 2005Groshong NXT Picc Catheters
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 Jan 21, 2004 as substantially equivalent to K023374 (C.R. Bard, Inc., 2002) after a 28-day review. Its family tree reaches back 2 generations to 1991. 1 later device descends from it. It has been recalled 4 times.
- Decided
- Jan 21, 2004
- Review
- 28 days
- Class
- Class II
- Product code
- LJS
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 2 generations to K904558 (1991). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK904558 Dual Lumen 5 FR Perip Cent Ven Cath W/Groshong ValDavol, Inc. · 1991
- 1 generation backK023374 Groshong NXT Dual Lumen Picc CathetersC.R. Bard, Inc. · 2002 · Recalled
- This deviceK034020 Groshong NXT Picc CathetersC.R. Bard, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK201452 Groshong NXT PICC CatheterC.R. Bard, Inc. · 2021 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K201452Groshong NXT PICC CatheterC.R. Bard, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K904558 | Dual Lumen 5 FR Perip Cent Ven Cath W/Groshong Val | Davol, Inc. | 1991 | — |
| −1 | K023374 | Groshong NXT Dual Lumen Picc Catheters | C.R. Bard, Inc. | 2002 | 5 |
| 0 (this device) | K034020 | Groshong NXT Picc Catheters | C.R. Bard, Inc. | 2004 | — |
| +1 | K201452 | Groshong NXT PICC Catheter | C.R. Bard, Inc. | 2021 | 19 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 |
|---|---|---|---|
| * | K023374 | Groshong NXT Dual Lumen Picc CathetersSummary page 1…Class II, 80 LJS - Long Term Intravascular Catheter Classification Panel: General Hospital Premarket Notification: K023374 6.4 Device Description The 4 Fr single lumen silicone Groshong® NXT PICC catheter is a 60 cm, trimmable catheter with… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201452 | Groshong NXT PICC Catheter | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 20, 2005 | Not classified | Z-0544-06 | Other | Multiple pages in the Instructions For Use booklet were missing print. Booklets were missing either pages 1,4,5,8,9,12,13,and 15, or 2,3,6,7,10,11,14, and 15. These pages contain product description, indications, contraindications… |
| Dec 20, 2005 | Not classified | Z-0541-06 | Other | Multiple pages in the Instructions For Use booklet were missing print. Booklets were missing either pages 1,4,5,8,9,12,13,and 15, or 2,3,6,7,10,11,14, and 15. These pages contain product description, indications, contraindications… |
| Dec 20, 2005 | Not classified | Z-0543-06 | Other | Multiple pages in the Instructions For Use booklet were missing print. Booklets were missing either pages 1,4,5,8,9,12,13,and 15, or 2,3,6,7,10,11,14, and 15. These pages contain product description, indications, contraindications… |
| Dec 20, 2005 | Not classified | Z-0542-06 | Other | Multiple pages in the Instructions For Use booklet were missing print. Booklets were missing either pages 1,4,5,8,9,12,13,and 15, or 2,3,6,7,10,11,14, and 15. These pages contain product description, indications, contraindications… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 11.8 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K201452 (C.R. Bard, Inc., 2021) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K023374.
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.
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/K034020 · printed Nov 5, 2026
Cite this page
510(k) Report. “K034020: Groshong NXT Picc Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K034020
Report an extraction error
Are you the manufacturer?
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