510(k) · Decided

Decided

Turbo-Flo Picc

K041849510(k) TraditionalDecided Jul 21, 2005378-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, Inc. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

Cleared on Jul 21, 2005 as substantially equivalent to K992198 (Cook, Inc., 1999) and 2 other predicates after a 378-day review. Its family tree reaches back 4 generations to 2000. 1 of the 16 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it.

Decided: Jul 21, 2005
Review: 378 days
Class: Class II
Product code: LJS
Recalls: None
Predicates: 3

Its longest line of descent runs back 4 generations to K001901 (2000). 7 ancestors in all, the oldest K862056 (1986). 8 later devices descend from it, 2 citing it directly. 1 of the 16 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 4 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
3 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
2 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
1 generation backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
This deviceK041849 Turbo-Flo PiccCook, Inc. · 2005
Descendant · cites it directly · 6 of its ownK082047 Securacath Catheter, Model SPK01Interrad Medical, Inc. · 2008
Descendant · 2 generations on · 5 of its ownK083081 Modification to Securacath, Model: SPK01Interrad Medical, Inc. · 2009
Descendant · 2 generations on · 4 of its ownK092306 Securacath UniversalInterrad Medical, Inc. · 2010
Descendant · 3 generations on · 3 of its ownK120935 SecuracathInterrad Medical, Inc. · 2012
Descendant · 4 generations on · 2 of its ownK180769 SecurAcathInterrad Medical, Inc. · 2018

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2008high 1 (2008) · low 0 (2011)2026

Class I recalls in this family

K862056 [Central Venous][Multi-Lumen] Catheter W/Flex Tip2 generations back · 1986

Most influential descendants

Showing 5 of 8 · See all

K082047Securacath Catheter, Model SPK01Interrad Medical, Inc. · 2008 · cites it directly6descendants
K083081Modification to Securacath, Model: SPK01Interrad Medical, Inc. · 2009 · 2 generations on5descendants
K092306Securacath UniversalInterrad Medical, Inc. · 2010 · 2 generations on4descendants
K120935SecuracathInterrad Medical, Inc. · 2012 · 3 generations on3descendants
K180769SecurAcathInterrad Medical, Inc. · 2018 · 4 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K001901	Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline…	C.R. Bard, Inc.	2000	2
−3	K012902	Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath…	C.R. Bard, Inc.	2001	—
−2	K031129	Poly Per-Q-Cath Picc Catheters; Poly Radpicc	C.R. Bard, Inc.	2003	—
−1	K033389	Powerpicc Catheters, Models 3175155, 3175135	C.R. Bard, Inc.	2004	1
0 (this device)	K041849	Turbo-Flo Picc	Cook, Inc.	2005	—
+1	K082047	Securacath Catheter, Model SPK01	Interrad Medical, Inc.	2008	—
+2	K083081	Modification to Securacath, Model: SPK01	Interrad Medical, Inc.	2009	—
+2	K092306	Securacath Universal	Interrad Medical, Inc.	2010	—
+3	K120935	Securacath	Interrad Medical, Inc.	2012	—
+4	K180769	SecurAcath	Interrad Medical, Inc.	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1986	1	1
1999	1	0
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2009	1	0
2010	1	0
2012	1	0
2016	1	0
2018	1	0
2019	1	0
2021	1	0

FIG. 1 — Lineage of K041849, 2000–2021Source: 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.

1 device in this family has 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? (3)

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
*	K992198	Urethane Picc Line Model Upics- Summary page 2 …/Ci Substantial Equivalence: Manufacturer Device 510(k) # Cook Incorporated Urethane PICC Line (Turbo-Flo®) K992198 ® Cook Incorporated Double Lumen Urethane PICC (Turbo-Flo ) K010034…	Cook, Inc.	1999	—
*	K010034	Double Lumen Urethane Picc Line, Model Upicds- Summary page 2 …Urethane PICC Line (Turbo-Flo®) K992198 ® Cook Incorporated Double Lumen Urethane PICC (Turbo-Flo ) K010034 CR Bard PowerPICCTM Catheters K033389 In terms of section 5 10(k) substantial equivalence, the Tu…	Cook, Inc.	2001	—
*	K033389	Powerpicc Catheters, Models 3175155, 3175135 Summary page 2 …® Cook Incorporated Double Lumen Urethane PICC (Turbo-Flo ) K010034 CR Bard PowerPICCTM Catheters K033389 In terms of section 5 10(k) substantial equivalence, the Turbo-Flo® PICC is similar in terms of material design, intended use an…	C.R. Bard, Inc.	2004	1

Also cleared against K992198: 1 other device →

What descends from it? (8)

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

Number	Device	Applicant	Decided	Descendants
K082047	Securacath Catheter, Model SPK01	Interrad Medical, Inc.	2008	6
K161496	Turbo-Flo PICC Sets	Cook Incorporated	2016	0

Has anything in its family been recalled? (1 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.

K862056[Central Venous][Multi-Lumen] Catheter W/Flex TipArrow Intl., Inc. · 1986 · 2 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
3 of the 7 ancestors have a recall of any class; 1 has a Class I recall.
Of its descendants, K082047 (Interrad Medical, Inc., 2008) has gone furthest, with 6 descendants of its own.
1 other device also cites its predicate K992198.

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?

Turbo-Flo® Peripherally Inserted Central Venous Catheters (PICC) are indicated 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 maximum pressure setting/limit of power injectors used with the Turbo-Flo PICC may not exceed 300 psi for the 5 Fr single lumen and 200 psi for the 4 Fr single lumen and 5 Fr double lumen. The Turbo-Flo PICC is indicated for a single injection of contrast media through a power injection.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041849 · printed Nov 5, 2026

Cite this page

510(k) Report. “K041849: Turbo-Flo Picc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041849

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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