510(k) · Cleared
ClearedTurbo-Ject Peripherally Inserted Central Venous Catheter (Picc) Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Oct 11, 2013 as substantially equivalent to K072625 (Cook, Inc., 2007) after a 25-day review. Its family tree reaches back 1 generation to 2007. 2 later devices descend from it.
- Decided
- Oct 11, 2013
- Review
- 25 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K072625 (2007). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK072625 Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc)Cook, Inc. · 2007 · Recalled
- This deviceK132885 Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc) SetCook Incorporated · 2013
- Descendant · cites it directly · 0 of its ownK141818 Turbo-Ject Picc SetsCook Corporated · 2014
- Descendant · cites it directly · 0 of its ownK133634 Spectrum Turbo-Ject Peripherally Inserted Central Venous Catheter SetCook, Inc. · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K072625 | Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc) | Cook, Inc. | 2007 | 9 |
| 0 (this device) | K132885 | Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc) Set | Cook Incorporated | 2013 | — |
| +1 | K141818 | Turbo-Ject Picc Sets | Cook Corporated | 2014 | — |
| +1 | K133634 | Spectrum Turbo-Ject Peripherally Inserted Central Venous Catheter Set | Cook, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 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? (1)
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 1…he maximum flow rate indicated. Predicate Devices: The Turbo-iecO' P1CC Sets, subject of this submission, are a modification to the Cook Incorporated Turbo-Ject® P1CC (K072625). which was cleared for commercial distribution on December 13. 2007. Comparison to Predicate Device: It has been demonstrated… | 2007 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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. 2013, 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 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/K132885 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132885: Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc) Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132885
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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