510(k) · Cleared
ClearedTurbo-Ject Peripherally Inserted Central Venous Catheter (Picc)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook, Inc. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Jun 14, 2011 as substantially equivalent to K072625 (Cook, Inc., 2007) and 1 other predicate after a 42-day review. Its family tree reaches back 5 generations to 1986. 2 of the 13 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Jun 14, 2011
- Review
- 42 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K862056 (1986). 11 ancestors in all. 1 later device descends from it, 1 citing it directly. 2 of the 13 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK862056 [Central Venous][Multi-Lumen] Catheter W/Flex TipArrow Intl., Inc. · 1986 · Recalled (Class I)
- 4 generations backK992198 Urethane Picc Line Model Upics-Cook, Inc. · 1999
- 3 generations backK021557 Spectrum Silicone CatheterCook, Inc. · 2003
- 2 generations backK081690 Spectrum Turbo-Ject Peripherally Inserted Central Venous CatheterCook, Inc. · 2008
- 1 generation backK100974 Spectrum Turbo-Ject Picc SetCook Incorporated · 2010
- This deviceK111244 Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc)Cook, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK141818 Turbo-Ject Picc SetsCook Corporated · 2014
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K141818Turbo-Ject Picc SetsCook Corporated · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K862056 | [Central Venous][Multi-Lumen] Catheter W/Flex Tip | Arrow Intl., Inc. | 1986 | Class I |
| −4 | K992198 | Urethane Picc Line Model Upics- | Cook, Inc. | 1999 | — |
| −3 | K021557 | Spectrum Silicone Catheter | Cook, Inc. | 2003 | — |
| −2 | K081690 | Spectrum Turbo-Ject Peripherally Inserted Central Venous Catheter | Cook, Inc. | 2008 | — |
| −1 | K100974 | Spectrum Turbo-Ject Picc Set | Cook Incorporated | 2010 | — |
| 0 (this device) | K111244 | Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc) | Cook, Inc. | 2011 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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.
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
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 | Decided |
|---|---|---|---|
| * | K072625 | Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc)Summary page 2…2011 Predicate Devices: Turbo-Ject® Peripherally Inserted Central Venous Catheter (P1CC), 5 10(k) number K072625 Spectrum®o Turbo-Ject® Peripherally Inserted Central… | 2007 |
| * | K100974 | Spectrum Turbo-Ject Picc SetSummary page 2…Spectrum®o Turbo-Ject® Peripherally Inserted Central Venous Catheter (P1CC), 5 10(k) number K 100974 Device Description: The Turbo-Ject® P1CC catheters are radiopaque polyurethane peripherally inserted central venous catheters f… | 2010 |
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 |
|---|---|---|---|
| K141818 | Turbo-Ject Picc Sets | 2014 | 0 |
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 · 4 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 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- 5 of the 11 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K141818 (Cook Corporated, 2014) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K072625.
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. 2011, 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 Turbo-Ject® P1CC is 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 Turbo-Ject® P1CC 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® P1CC may not exceed 325 psi and the flow rate may not…
Read the full statement (214 words)
The Turbo-Ject® P1CC is 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 Turbo-Ject® P1CC 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® P1CC may not exceed 325 psi and the flow rate may not exceed the maximum flow rate indicated.
Catheter Size | Maximum Flow Rate* | Injection Pressure Limit Setting
3.0 Fr Single Lumen | 2 mL/sec | 325 psi
4.0 Fr Single Lumen | 4 mL/sec | 325 psi
4.0 Fr Double Lumen | 3 mL/sec | 325 psi
5.0 Fr Single Lumen | 7 mL/sec | 325 psi
5.0 Fr Double Lumen | 5 mL/sec | 325 psi
6.0 Fr Triple Lumen** | 7 mL/sec | 325 psi
*Flow rates achieved using room temperature Omnipaque 300® contrast and verified using a Medrad Stellant® CT injector system. Omnipaque 300 has a viscosity of 11.8 centipoise at room temperature (20 degrees C). A change in temperature or viscosity of the contrast medium used will result in a change in achievable flow rates.
**Lumen #1 only.
Omnipaque 300® is a registered trademark of GE Healthcare.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111244 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111244: Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111244
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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