510(k) · Cleared
ClearedSpectrum Turbo-Ject Peripherally Inserted Central Venous Catheter Set
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 23, 2013 as substantially equivalent to K081690 (Cook, Inc., 2008) and 3 other predicates after a 27-day review. Its family tree reaches back 4 generations to 1986. 2 of the 13 devices in its family, counting itself, have a Class I recall.
- Decided
- Dec 23, 2013
- Review
- 27 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K862056 (1986). 12 ancestors in all. No later device cites it as a predicate yet. 2 of the 13 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK862056 [Central Venous][Multi-Lumen] Catheter W/Flex TipArrow Intl., Inc. · 1986 · Recalled (Class I)
- 3 generations backK992198 Urethane Picc Line Model Upics-Cook, Inc. · 1999
- 2 generations backK021557 Spectrum Silicone CatheterCook, Inc. · 2003
- 1 generation backK081690 Spectrum Turbo-Ject Peripherally Inserted Central Venous CatheterCook, Inc. · 2008
- This deviceK133634 Spectrum Turbo-Ject Peripherally Inserted Central Venous Catheter SetCook, Inc. · 2013
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K862056 | [Central Venous][Multi-Lumen] Catheter W/Flex Tip | Arrow Intl., Inc. | 1986 | Class I |
| −3 | K992198 | Urethane Picc Line Model Upics- | Cook, Inc. | 1999 | — |
| −2 | K021557 | Spectrum Silicone Catheter | Cook, Inc. | 2003 | — |
| −1 | K081690 | Spectrum Turbo-Ject Peripherally Inserted Central Venous Catheter | Cook, Inc. | 2008 | — |
| 0 (this device) | K133634 | Spectrum Turbo-Ject Peripherally Inserted Central Venous Catheter Set | Cook, Inc. | 2013 | — |
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 |
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? (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 | Decided |
|---|---|---|---|
| * | K081690 | Spectrum Turbo-Ject Peripherally Inserted Central Venous CatheterSummary page 1…flow rate indicated. Predicate Devices: The Spectrum Turho-Ject® P1CC Sets, subject of this submission, are modifications to the following Cook Incorporated PICCs: 0K08 1690, Spectrum Turbo-Ject®o Peripherally Inserted Central Venous Catheter o K072625, Turbo-Ject® Peripherally Inserted Cent… | 2008 |
| * | K072625 | Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc)Summary page 1…submission, are modifications to the following Cook Incorporated PICCs: 0K08 1690, Spectrum Turbo-Ject®o Peripherally Inserted Central Venous Catheter o K072625, Turbo-Ject® Peripherally Inserted Central Venous Catheter K132334 & K 132885, modifications to add minimal ta… | 2007 |
| * | K132334 | Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc) SetSummary page 1…0, Spectrum Turbo-Ject®o Peripherally Inserted Central Venous Catheter o K072625, Turbo-Ject® Peripherally Inserted Central Venous Catheter K132334 & K 132885, modifications to add minimal taper design 5 10(k) Summary -… | 2013 |
| * | K132885 | Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc) SetSummary page 1…m Turbo-Ject®o Peripherally Inserted Central Venous Catheter o K072625, Turbo-Ject® Peripherally Inserted Central Venous Catheter K132334 & K 132885, modifications to add minimal taper design 5 10(k) Summary -… | 2013 |
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 · 3 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 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 27 years and passes through 2 companies; a new generation was cleared every 5.4 years on median.
- 5 of the 12 ancestors have a recall of any class; 2 have a Class I recall.
- 1 other device also cites its predicate K081690.
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?
Spectrum 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 catheter is impregnated with the antimicrobials minocycline and rifampin to help provide protection against catheter-related bloodstream infections (CRBSIs). The…
Read the full statement (108 words)
Spectrum 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 catheter is impregnated with the antimicrobials minocycline and rifampin to help provide protection against catheter-related bloodstream infections (CRBSIs). The Spectrum 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 Spectrum 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/K133634 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133634: Spectrum Turbo-Ject Peripherally Inserted Central Venous Catheter Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133634
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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