510(k) · Cleared
ClearedSilicone Peripherally Inserted Central Venous Catheter Set/Tray
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 Feb 22, 2018 as substantially equivalent to K030270 (Medcomp, 2003) and 1 other predicate after a 234-day review. Its family tree reaches back 3 generations to 1986. 2 of the 10 devices in its family, counting itself, have a Class I recall.
- Decided
- Feb 22, 2018
- Review
- 234 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K862056 (1986). 9 ancestors in all. No later device cites it as a predicate yet. 2 of the 10 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK862056 [Central Venous][Multi-Lumen] Catheter W/Flex TipArrow Intl., Inc. · 1986 · Recalled (Class I)
- 2 generations backK992198 Urethane Picc Line Model Upics-Cook, Inc. · 1999
- 1 generation backK021557 Spectrum Silicone CatheterCook, Inc. · 2003
- This deviceK171994 Silicone Peripherally Inserted Central Venous Catheter Set/TrayCook Incorporated · 2018
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K862056 | [Central Venous][Multi-Lumen] Catheter W/Flex Tip | Arrow Intl., Inc. | 1986 | Class I |
| −2 | K992198 | Urethane Picc Line Model Upics- | Cook, Inc. | 1999 | — |
| −1 | K021557 | Spectrum Silicone Catheter | Cook, Inc. | 2003 | — |
| 0 (this device) | K171994 | Silicone Peripherally Inserted Central Venous Catheter Set/Tray | Cook Incorporated | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 2 | 1 |
| 2001 | 2 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K030270 | 3F X 60 CM Single Lumen Silisone Vascu-Picc, 4F X 60CM Single Lumen Silicone Vascu-Picc…Summary page 4…ted Central Venous Catheter Set/Tray is substantially equivalent to the following: - Primary Predicate: Medcomp Vascu-PICC™ Catheter cleared on April 11, 2003 (K030270). - Secondary Predicate: Cook Spectrum Silicone Catheter cleared on May 30, 2003 (K021557). Cook Incorp… | 2003 |
| * | K021557 | Spectrum Silicone CatheterSummary page 4…icate: Medcomp Vascu-PICC™ Catheter cleared on April 11, 2003 (K030270). - Secondary Predicate: Cook Spectrum Silicone Catheter cleared on May 30, 2003 (K021557). Cook Incorporated – Traditional 510(k) 4 Silicone Periphe… | 2003 |
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 · 2 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 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 32 years and passes through 3 companies; a new generation was cleared every 13.0 years on median.
- 4 of the 9 ancestors have a recall of any class; 2 have a Class I recall.
- 3 other devices also cite its predicate K030270.
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. 2018, 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 Silicone Peripherally Inserted Central Venous Catheter Set/Tray is intended for delivery of whole blood or blood products, drug administration and blood sampling.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171994 · printed Nov 4, 2026
Cite this page
510(k) Report. “K171994: Silicone Peripherally Inserted Central Venous Catheter Set/Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K171994
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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