510(k) · Cleared

Recalled · Class II · 2014

Groshong NXT Dual Lumen Picc Catheters

K023374510(k) AbbreviatedCleared Dec 18, 200271-day reviewClass II21 CFR 880.5970Recalls 5

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

C.R. Bard, Inc. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

Cleared on Dec 18, 2002 as substantially equivalent to K904558 (Davol, Inc., 1991) and 1 other predicate after a 71-day review. Its family tree reaches back 1 generation to 1991. 7 of the 56 devices in its family, counting itself, have a Class I recall. 53 later devices descend from it. It has been recalled 5 times.

Decided: Dec 18, 2002
Review: 71 days
Class: Class II
Product code: LJS
Recalls: 5
Predicates: 2

Its longest line of descent runs back 1 generation to K904558 (1991). 2 ancestors in all. 53 later devices descend from it, 3 citing it directly. 7 of the 56 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK904558 Dual Lumen 5 FR Perip Cent Ven Cath W/Groshong ValDavol, Inc. · 1991
This deviceK023374 Groshong NXT Dual Lumen Picc CathetersC.R. Bard, Inc. · 2002
Descendant · cites it directly · 43 of its ownK060341 Sherlock Tip Location System (TLS)C.R. Bard, Inc. · 2006
Descendant · 2 generations on · 42 of its ownK063240 Sherlock TLS Stylet, Sherlock TLS DetectorC.R. Bard, Inc. · 2006 · Recalled
Descendant · 3 generations on · 40 of its ownK081625 Flowpicc StyletVasonova, Inc. · 2008
Descendant · 3 generations on · 39 of its ownK081626 Flowpicc ConsoleVasonova, Inc. · 2008
Descendant · 3 generations on · 38 of its ownK091324 Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning…C.R. Bard, Inc. · 2009 · Recalled

Showing 5 of 53 descendants. See all descendants

Descendants cleared per year

2004high 5 (2013) · low 0 (2005)2026

Class I recalls in this family

K210264 BD PowerPiCC Catheter3 generations on · 2021
K122545 CG+ Arrow Picc Powered by Arrow VPS Stylet5 generations on · 2012
K132133 CG+ Arrow Jacc Powered by Arrow VPS Stylet5 generations on · 2013
K130876 CG+ Arrow Picc Powered by Arrow VPS Stylet6 generations on · 2013

Most influential descendants

Showing 5 of 53 · See all

K060341Sherlock Tip Location System (TLS)C.R. Bard, Inc. · 2006 · cites it directly43descendants
K063240Sherlock TLS Stylet, Sherlock TLS DetectorC.R. Bard, Inc. · 2006 · 2 generations on42descendants
K081625Flowpicc StyletVasonova, Inc. · 2008 · 3 generations on40descendants
K081626Flowpicc ConsoleVasonova, Inc. · 2008 · 3 generations on39descendants
K091324Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System StyletC.R. Bard, Inc. · 2009 · 3 generations on38descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K904558	Dual Lumen 5 FR Perip Cent Ven Cath W/Groshong Val	Davol, Inc.	1991	—
0 (this device)	K023374	Groshong NXT Dual Lumen Picc Catheters	C.R. Bard, Inc.	2002	—
+1	K060341	Sherlock Tip Location System (TLS)	C.R. Bard, Inc.	2006	—
+2	K063240	Sherlock TLS Stylet, Sherlock TLS Detector	C.R. Bard, Inc.	2006	18
+3	K081625	Flowpicc Stylet	Vasonova, Inc.	2008	—
+3	K081626	Flowpicc Console	Vasonova, Inc.	2008	—
+3	K091324	Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System Stylet	C.R. Bard, Inc.	2009	11

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
2004	1	0
2006	2	0
2007	2	0
2008	2	0
2009	1	0
2010	2	0
2011	3	0
2012	3	1
2013	5	2
2014	5	0
2015	5	0
2016	5	3
2017	3	0
2018	3	0
2021	3	1
2022	2	0
2024	1	0
2025	4	0
2026	1	0

FIG. 1 — Lineage of K023374, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

7 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 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

Get a 510(k) Report

What was it cleared against? (2)

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	Applicant	Decided	Recalls
*	K904558	Dual Lumen 5 FR Perip Cent Ven Cath W/Groshong Val Summary page 1 …Class 11, 80 LJS - Long Term Intravascular Catheter Classification Panel: General Hospital Premarket Notification: K904558, concurrence date February 11, 1991 K92633 1, concurrence date March 11, 1994 6.4…	Davol, Inc.	1991	—
*	K926331	3.0 FR Groshong Peripher Insert Cent Venous Cath Summary page 1 …anel: General Hospital Premarket Notification: K904558, concurrence date February 11, 1991 K92633 1, concurrence date March 11, 1994 6.4 Device Description The 5 Fr Dual Lumen silicone GroshongB NXT PICC Cathete…	Bard Access Systems, Inc.	1994	1

What descends from it? (53)

See all 53

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K060341	Sherlock Tip Location System (TLS)	C.R. Bard, Inc.	2006	43
K063848	Powergroshong Picc Catheter	C.R. Bard, Inc.	2007	6
K034020	Groshong NXT Picc Catheters	C.R. Bard, Inc.	2004	1

Has anything in its family been recalled? (7 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 8, 2014	Class II	Z-1271-2015	Nonconforming Material/Component	Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some configurations of PICC kits, Port Access kits (PAK)…
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…

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.

K210264BD PowerPiCC CatheterBard Access Systems, Inc. · 2021 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
K122545CG+ Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
K132133CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2013 · 5 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
K130876CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. · 2013 · 6 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
K153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016 · 6 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
K153487CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUSArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016 · 6 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
K160925VPS Rhythm Device with TipTracker TechnologyArrow International, Inc. (A Subsidiary of Teleflex, Inc.) · 2016 · 7 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall

Nearest 5 of 7; all are on the web page.

What does this lineage say?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K060341 (C.R. Bard, Inc., 2006) has gone furthest, with 43 descendants of its own.

How does its category compare?

All LJS devices

LJS 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

2007high 16 (2009) · low 0 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LJS

171in 2025

2007high 284 (2021) · low 31 (2013)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LJS

5in 2023

2007high 40 (2012) · low 0 (2007)2026

Class I (3 since 2007) Class II/III not classified

Adverse event reports per year · LJS

4,372in 2025

2007high 4,372 (2025) · low 369 (2008)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/K023374 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023374: Groshong NXT Dual Lumen Picc Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023374

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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