510(k) · Cleared
Clearedpilot TLS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vygon Corporation · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Feb 26, 2025 as substantially equivalent to K170934 (Medical Components, Inc (Dba Medcomp_, 2017) after a 268-day review. Its family tree reaches back 12 generations to 2000.
- Decided
- Feb 26, 2025
- Review
- 268 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K001901 (2000). 35 ancestors in all, the oldest K823434 (1982). No later device cites it as a predicate yet.
- Root · 12 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 8 generations between
- 3 generations backK140799 Celerity SysyemMedcomp (Medical Components, Inc.) · 2014 · Recalled
- 2 generations backK143238 C3 WaveMedcomp ( Medical Components) · 2015
- 1 generation backK170934 C3 Wave SystemMedical Components, Inc (Dba Medcomp_ · 2017 · Recalled
- This deviceK241587 pilot TLSVygon Corporation · 2025
Show all 12 generations
- Root · 12 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 11 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 10 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 9 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 8 generations backK060341 Sherlock Tip Location System (TLS)C.R. Bard, Inc. · 2006
- 7 generations backK063240 Sherlock TLS Stylet, Sherlock TLS DetectorC.R. Bard, Inc. · 2006 · Recalled
- 6 generations backK081625 Flowpicc StyletVasonova, Inc. · 2008
- 5 generations backK091324 Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning…C.R. Bard, Inc. · 2009 · Recalled
- 4 generations backK093775 Evguide Tip Location SystemRomedex International Srl · 2010
- 3 generations backK140799 Celerity SysyemMedcomp (Medical Components, Inc.) · 2014 · Recalled
- 2 generations backK143238 C3 WaveMedcomp ( Medical Components) · 2015
- 1 generation backK170934 C3 Wave SystemMedical Components, Inc (Dba Medcomp_ · 2017 · Recalled
- This deviceK241587 pilot TLSVygon Corporation · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −11 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −10 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −9 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −8 | K060341 | Sherlock Tip Location System (TLS) | C.R. Bard, Inc. | 2006 | — |
| −7 | K063240 | Sherlock TLS Stylet, Sherlock TLS Detector | C.R. Bard, Inc. | 2006 | 18 |
| −6 | K081625 | Flowpicc Stylet | Vasonova, Inc. | 2008 | — |
| −5 | K091324 | Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System Stylet | C.R. Bard, Inc. | 2009 | 11 |
| −4 | K093775 | Evguide Tip Location System | Romedex International Srl | 2010 | — |
| −3 | K140799 | Celerity Sysyem | Medcomp (Medical Components, Inc.) | 2014 | 1 |
| −2 | K143238 | C3 Wave | Medcomp ( Medical Components) | 2015 | — |
| −1 | K170934 | C3 Wave System | Medical Components, Inc (Dba Medcomp_ | 2017 | 1 |
| 0 (this device) | K241587 | pilot TLS | Vygon Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 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.
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 |
|---|---|---|---|
| * | K170934 | C3 Wave SystemSummary page 5…catheter. Classification Name Class II, 21 CFR Section 880.5970- LJS (Catheter, intravascular, Therapeutic Long-Term Greater Than 30 Days). Predicate Device C3 Wave (K170934) manufactured by Medcomp (dba Medical Components Inc.). Device Description Pilot TLS is designed to support guidance and tip po… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 25 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- 9 of the 35 ancestors have a recall of any class.
- 1 other device also cites its predicate K170934.
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. 2025, 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 Pilot TLS is indicated for use in positioning of PICCs. The Pilot TLS provides real-time catheter tip location information by displaying changes in the patient's cardiac electrical activity. Pilot TLS is indicated for use as an alternative method to chest X-ray or fluoroscopy confirmation of PICC tip placement in adult patients. Note: Limited, but not contraindicated, situations for this technique are patients where cardiac rhythms may change…
Read the full statement (110 words)
The Pilot TLS is indicated for use in positioning of PICCs. The Pilot TLS provides real-time catheter tip location information by displaying changes in the patient's cardiac electrical activity. Pilot TLS is indicated for use as an alternative method to chest X-ray or fluoroscopy confirmation of PICC tip placement in adult patients.
Note: Limited, but not contraindicated, situations for this technique are patients where cardiac rhythms may change presentation of the P-wave:
- Atrial fibrillation
- Atrial flutter
- Severe tachycardia
- Pacemaker-Driven Rhythm
- Chronic obstructive pulmonary disease (COPD)
Such patients are easily identified prior to PICC insertion. Use of additional method is necessary to confirm catheter tip location.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241587 · printed Nov 4, 2026
Cite this page
510(k) Report. “K241587: pilot TLS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K241587
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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