510(k) · Cleared
Recalled · 2010Turbo-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 Dec 13, 2007 after an 87-day review. The FDA summary names no predicate by number. 7 later devices descend from it. It has been recalled 9 times.
- Decided
- Dec 13, 2007
- Review
- 87 days
- Class
- Class II
- Product code
- LJS
- Recalls
- 9
- Predicates
- 0
7 later devices descend from it, 6 citing it directly.
- This deviceK072625 Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc)Cook, Inc. · 2007
- Descendant · cites it directly · 4 of its ownK081690 Spectrum Turbo-Ject Peripherally Inserted Central Venous CatheterCook, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK132885 Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc) SetCook Incorporated · 2013
- Descendant · cites it directly · 2 of its ownK132334 Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc) SetCook, Inc. · 2013
- Descendant · 2 generations on · 2 of its ownK100974 Spectrum Turbo-Ject Picc SetCook Incorporated · 2010
- Descendant · cites it directly · 1 of its ownK111244 Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc)Cook, Inc. · 2011
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K081690Spectrum Turbo-Ject Peripherally Inserted Central Venous CatheterCook, Inc. · 2008 · cites it directly4descendants
- K132885Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc) SetCook Incorporated · 2013 · cites it directly2descendants
- K132334Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc) SetCook, Inc. · 2013 · cites it directly2descendants
- K100974Spectrum Turbo-Ject Picc SetCook Incorporated · 2010 · 2 generations on2descendants
- K111244Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc)Cook, Inc. · 2011 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K072625 | Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc) | Cook, Inc. | 2007 | — |
| +1 | K081690 | Spectrum Turbo-Ject Peripherally Inserted Central Venous Catheter | Cook, Inc. | 2008 | — |
| +1 | K132885 | Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc) Set | Cook Incorporated | 2013 | — |
| +1 | K132334 | Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc) Set | Cook, Inc. | 2013 | — |
| +2 | K100974 | Spectrum Turbo-Ject Picc Set | Cook Incorporated | 2010 | — |
| +1 | K111244 | Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc) | Cook, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 3 | 0 |
| 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.
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?
The FDA summary names no predicate by number.
What descends from it? (7)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081690 | Spectrum Turbo-Ject Peripherally Inserted Central Venous Catheter | 2008 | 4 |
| K132885 | Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc) Set | 2013 | 2 |
| K132334 | Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc) Set | 2013 | 2 |
| K111244 | Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc) | 2011 | 1 |
| K141818 | Turbo-Ject Picc Sets | 2014 | 0 |
| K133634 | Spectrum Turbo-Ject Peripherally Inserted Central Venous Catheter Set | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 4, 2010 | Not classified | Z-1186-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1187-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1188-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1189-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1181-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1183-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1182-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1185-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1184-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K081690 (Cook, Inc., 2008) has gone furthest, with 4 descendants of its own.
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. 2007, 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?
Turbo-Ject 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 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…
Read the full statement (202 words)
Turbo-Ject 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 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 rated indicated, as shown on the following table.
Catheter Size | Maximum Flow Rate* | Injection Pressure Limit Setting
4 Fr Single Lumen | 4 ml/sec | 325 psi
4 Fr Double Lumen | 3mI/sec | 325 psi
5 Fr Single Lumen | 7 ml/sec | 325 psi
5 Fr Double Lumen | 5 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 cenripoise 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. Omnipaque 300® is a registered trademark of Amersham Health, New Jersey
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072625 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072625: 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 5, 2026. https://510kreport.com/device/K072625
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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