510(k) · Cleared

Cleared

Turbo-Ject Picc Sets

K141818510(k) SpecialCleared Aug 5, 201429-day reviewClass II21 CFR 880.5970

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

Cook Corporated · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

Cleared on Aug 5, 2014 as substantially equivalent to K072625 (Cook, Inc., 2007) and 3 other predicates after a 29-day review. Its family tree reaches back 6 generations to 1986. 2 of the 15 devices in its family, counting itself, have a Class I recall.

Decided: Aug 5, 2014
Review: 29 days
Class: Class II
Product code: LJS
Recalls: None
Predicates: 4

Its longest line of descent runs back 6 generations to K862056 (1986). 14 ancestors in all. No later device cites it as a predicate yet. 2 of the 15 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 6 generations backK862056 [Central Venous][Multi-Lumen] Catheter W/Flex TipArrow Intl., Inc. · 1986 · Recalled (Class I)
5 generations backK992198 Urethane Picc Line Model Upics-Cook, Inc. · 1999
4 generations backK021557 Spectrum Silicone CatheterCook, Inc. · 2003
3 generations backK081690 Spectrum Turbo-Ject Peripherally Inserted Central Venous CatheterCook, Inc. · 2008
2 generations backK100974 Spectrum Turbo-Ject Picc SetCook Incorporated · 2010
1 generation backK111244 Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc)Cook, Inc. · 2011
This deviceK141818 Turbo-Ject Picc SetsCook Corporated · 2014

Class I recalls in this family

K993691 Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen…5 generations back · 2000
K862056 [Central Venous][Multi-Lumen] Catheter W/Flex Tip6 generations back · 1986

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K862056	[Central Venous][Multi-Lumen] Catheter W/Flex Tip	Arrow Intl., Inc.	1986	Class I
−5	K992198	Urethane Picc Line Model Upics-	Cook, Inc.	1999	—
−4	K021557	Spectrum Silicone Catheter	Cook, Inc.	2003	—
−3	K081690	Spectrum Turbo-Ject Peripherally Inserted Central Venous Catheter	Cook, Inc.	2008	—
−2	K100974	Spectrum Turbo-Ject Picc Set	Cook Incorporated	2010	—
−1	K111244	Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc)	Cook, Inc.	2011	—
0 (this device)	K141818	Turbo-Ject Picc Sets	Cook Corporated	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
2000	2	1
2001	2	0
2007	1	0
2013	2	0

FIG. 1 — Lineage of K141818, 1986–2014Source: 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.

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 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

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What was it cleared against? (4)

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
*	K072625	Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc) Summary page 4 …ntravascular, therapeutic, long-term greater than 30 days Regulation: 21 CFR §880.5970 Product Code LJS Predicate Devices: x K072625, Turbo-Ject Peripherally Inserted Central Venous Catheter (PICC) x K111244, Turbo-Ject® PICC Set x K132334, Turbo-Ject®…	Cook, Inc.	2007	9
*	K111244	Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc) Summary page 4 …21 CFR §880.5970 Product Code LJS Predicate Devices: x K072625, Turbo-Ject Peripherally Inserted Central Venous Catheter (PICC) x K111244, Turbo-Ject® PICC Set x K132334, Turbo-Ject® Peripherally Inserted Central Venous Catheter Set x K132885, Turbo-Ject®…	Cook, Inc.	2011	—
*	K132334	Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc) Set Summary page 4 …Code LJS Predicate Devices: x K072625, Turbo-Ject Peripherally Inserted Central Venous Catheter (PICC) x K111244, Turbo-Ject® PICC Set x K132334, Turbo-Ject® Peripherally Inserted Central Venous Catheter Set x K132885, Turbo-Ject® Peripherally Inserted Central Venous…	Cook, Inc.	2013	—
*	K132885	Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc) Set Summary page 4 …herally Inserted Central Venous Catheter (PICC) x K111244, Turbo-Ject® PICC Set x K132334, Turbo-Ject® Peripherally Inserted Central Venous Catheter Set x K132885, Turbo-Ject® Peripherally Inserted Central Venous Catheter Set Device Description: The 3.0, 4.0, 5.0, and 6.0 Fr Turbo-Ject PICC…	Cook Incorporated	2013	—

Also cleared against K072625: 5 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

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 · 5 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 · 6 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
5 of the 14 ancestors have a recall of any class; 2 have a Class I recall.
5 other devices also cite its predicate K072625.

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. 2014, this device’s year, is highlighted.

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?

Turbo-Ject Peripherally Inserted Central Venous Catheter (PICC) Sets and Trays are intended for short- or long-term use

for venous pressure monitoring, blood sampling, administration of drugs and fluids, and for use with power injectors for

delivery of contrast in CT studies. The Turbo-Ject PICC is indicated for multiple injections of contrast media through a

power injector. The maximum pressure limit setting for Power Injectors used with the Turbo-Ject PICC may not exceed

325 psi and the flow rate may not exceed the maximum flow rate indicated.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K141818 · printed Nov 6, 2026

Cite this page

510(k) Report. “K141818: Turbo-Ject Picc Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141818

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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