510(k) · Cleared
ClearedJet Power Injectable PICC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jet Medical, Inc. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Nov 21, 2018 as substantially equivalent to K091953 (Medcomp, 2009) after a 265-day review. Its family tree reaches back 9 generations to 2000. 2 of the 26 devices in its family, counting itself, have a Class I recall.
- Decided
- Nov 21, 2018
- Review
- 265 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K001901 (2000). 25 ancestors in all, the oldest K830256 (1983). No later device cites it as a predicate yet. 2 of the 26 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 5 generations between
- 3 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- 2 generations backK070996 4 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc. · 2007
- 1 generation backK091953 Pro-PiccMedcomp · 2009
- This deviceK180546 Jet Power Injectable PICCJet Medical, Inc. · 2018
Show all 9 generations
- Root · 9 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 8 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 7 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 6 generations backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
- 5 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
- 4 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
- 3 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- 2 generations backK070996 4 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc. · 2007
- 1 generation backK091953 Pro-PiccMedcomp · 2009
- This deviceK180546 Jet Power Injectable PICCJet Medical, Inc. · 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 |
|---|---|---|---|---|---|
| −9 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −8 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −7 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −6 | K033389 | Powerpicc Catheters, Models 3175155, 3175135 | C.R. Bard, Inc. | 2004 | 1 |
| −5 | K050185 | Powerhohn and Powerline Catheters | C.R. Bard, Inc. | 2005 | — |
| −4 | K051417 | 6 FR FL Powerhohn and Powerline Catheter | C.R. Bard, Inc. | 2005 | 1 |
| −3 | K051991 | Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line | C.R. Bard, Inc. | 2005 | — |
| −2 | K070996 | 4 FR Single Lumen (SL) Powerpicc Catheter | C.R. Bard, Inc. | 2007 | — |
| −1 | K091953 | Pro-Picc | Medcomp | 2009 | — |
| 0 (this device) | K180546 | Jet Power Injectable PICC | Jet Medical, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 1 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 1 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2008 | 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? (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 |
|---|---|---|---|
| * | K091953 | Pro-PiccSummary page 4…Intravascular, Therapeutic, Long- Term Greater Than 30 Days Percutaneous, Implanted, Long-Term Intravascular Catheter LJS 880.5970 Il General Hospital PRO-PICC® CT K091953 Medical Components Inc. Catheter, Intravascular, Therapeutic, Long- Term Greater Than 30 Days Percutaneous, Implanted, Long-Ter… | 2009 |
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 · 5 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 · 6 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 12 of the 25 ancestors have a recall of any class; 2 have a Class I recall.
- 7 other devices also cite its predicate K091953.
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 Jet Power Injectable PICC is indicated for short term or long term peripheral access to the central venous system for
intravenous therapy and power injection of contrast media, and allows for central venous pressure monitoring. For blood
sampling, infusion, or therapies, use a 4F or larger catheter.
The maximum recommended infusion rate varies by catheter, The maximum recommended infusion rate for the 3F Jet
Power Injectable PICC is 1cc/sec and 5.0cc/sec for the 4F and 5F Jet Power Injectable PICC.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K180546 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180546: Jet Power Injectable PICC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180546
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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