510(k) · Cleared
Recalled · Class II · 2021Sherlock TLS Stylet, Sherlock TLS Detector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Nov 21, 2006 as substantially equivalent to K060341 (C.R. Bard, Inc., 2006) and 1 other predicate after a 26-day review. Its family tree reaches back 5 generations to 2000. 6 of the 54 devices in its family, counting itself, have a Class I recall. 42 later devices descend from it. It has been recalled 18 times.
- Decided
- Nov 21, 2006
- Review
- 26 days
- Class
- Class II
- Product code
- LJS
- Recalls
- 18
- Predicates
- 2
Its longest line of descent runs back 5 generations to K001901 (2000). 11 ancestors in all, the oldest K904558 (1991). 42 later devices descend from it, 3 citing it directly. 6 of the 54 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 4 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 3 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 2 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 1 generation backK060341 Sherlock Tip Location System (TLS)C.R. Bard, Inc. · 2006
- This deviceK063240 Sherlock TLS Stylet, Sherlock TLS DetectorC.R. Bard, Inc. · 2006
- Descendant · cites it directly · 40 of its ownK081625 Flowpicc StyletVasonova, Inc. · 2008
- Descendant · cites it directly · 39 of its ownK081626 Flowpicc ConsoleVasonova, Inc. · 2008
- Descendant · cites it directly · 38 of its ownK091324 Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning…C.R. Bard, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 34 of its ownK093775 Evguide Tip Location SystemRomedex International Srl · 2010
- Descendant · 3 generations on · 13 of its ownK140799 Celerity SysyemMedcomp (Medical Components, Inc.) · 2014 · Recalled
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
2008high 5 (2015) · low 0 (2019)2026
Class I recalls in this family
- K122545 CG+ Arrow Picc Powered by Arrow VPS Stylet3 generations on · 2012
- K132133 CG+ Arrow Jacc Powered by Arrow VPS Stylet3 generations on · 2013
- K130876 CG+ Arrow Picc Powered by Arrow VPS Stylet4 generations on · 2013
- K153423 CG+ Arrow JACC powered by Arrow VPS Stylet, CG+…4 generations on · 2016
Most influential descendants
Showing 5 of 42 · See all- K081625Flowpicc StyletVasonova, Inc. · 2008 · cites it directly40descendants
- K081626Flowpicc ConsoleVasonova, Inc. · 2008 · cites it directly39descendants
- K091324Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System StyletC.R. Bard, Inc. · 2009 · cites it directly38descendants
- K093775Evguide Tip Location SystemRomedex International Srl · 2010 · 2 generations on34descendants
- K140799Celerity SysyemMedcomp (Medical Components, Inc.) · 2014 · 3 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −4 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −3 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −2 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −1 | K060341 | Sherlock Tip Location System (TLS) | C.R. Bard, Inc. | 2006 | — |
| 0 (this device) | K063240 | Sherlock TLS Stylet, Sherlock TLS Detector | C.R. Bard, Inc. | 2006 | — |
| +1 | K081625 | Flowpicc Stylet | Vasonova, Inc. | 2008 | — |
| +1 | K081626 | Flowpicc Console | Vasonova, Inc. | 2008 | — |
| +1 | K091324 | Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System Stylet | C.R. Bard, Inc. | 2009 | 11 |
| +2 | K093775 | Evguide Tip Location System | Romedex International Srl | 2010 | — |
| +3 | K140799 | Celerity Sysyem | Medcomp (Medical Components, Inc.) | 2014 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 1 |
| 2013 | 4 | 2 |
| 2014 | 4 | 0 |
| 2015 | 5 | 0 |
| 2016 | 4 | 3 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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.
6 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 |
|---|---|---|---|
| * | K060341 | Sherlock Tip Location System (TLS)Summary page 1…Intravascular Catheter 21 CFR 880.5970- Class II Classification Panel: General Hospital Premarket Notification: K060341, concurrence date April 14, 2006 Device Name: Sherlock TM Tip Location System (TLS) Detector Trade Name:… | 2006 |
| * | K061240 | Sherlock Tip Location System (TLS) Detector and AccessoriesSummary page 1…Intravascular Catheter 21 CFR 880.5970- Class II Classification Panel: General Hospital Premarket Notification: K061240, concurrence date June 2, 2006 4. Device Description The SherlockTM Tip Location System (TLS) consists of the SherlockTh… | 2006 |
What descends from it? (42)
See all 423 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (6 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 7, 2021 | Class II | Z-1661-2021 | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the… |
| Apr 7, 2021 | Class II | Z-1653-2021 | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the… |
| Apr 7, 2021 | Class II | Z-1656-2021 | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the… |
| Apr 7, 2021 | Class II | Z-1668-2021 | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the… |
| Apr 7, 2021 | Class II | Z-1662-2021 | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the… |
| Apr 7, 2021 | Class II | Z-1659-2021 | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the… |
| Apr 7, 2021 | Class II | Z-1664-2021 | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the… |
| Apr 7, 2021 | Class II | Z-1657-2021 | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the… |
| Apr 7, 2021 | Class II | Z-1663-2021 | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the… |
| Apr 7, 2021 | Class II | Z-1660-2021 | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the… |
| Apr 7, 2021 | Class II | Z-1654-2021 | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the… |
| Apr 7, 2021 | Class II | Z-1665-2021 | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the… |
| Apr 7, 2021 | Class II | Z-1652-2021 | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the… |
| Apr 7, 2021 | Class II | Z-1669-2021 | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the… |
| Apr 7, 2021 | Class II | Z-1667-2021 | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the… |
| Apr 7, 2021 | Class II | Z-1655-2021 | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the… |
| Apr 7, 2021 | Class II | Z-1666-2021 | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the… |
| Apr 7, 2021 | Class II | Z-1658-2021 | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the… |
The 5 latest of 18 recalls; the web page lists all.
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.
- K122545CG+ Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K132133CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K130876CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K153487CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUSArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K160925VPS Rhythm Device with TipTracker TechnologyArrow International, Inc. (A Subsidiary of Teleflex, Inc.) · 2016 · 5 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 6 years and passes through 1 company; a new generation was cleared every 12 months on median.
- 4 of the 11 ancestors have a recall of any class.
- Of its descendants, K081625 (Vasonova, Inc., 2008) has gone furthest, with 40 descendants of its own.
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.
FDA decisions per year · LJS
8in 2025
2007high 16 (2009) · low 0 (2019)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · LJS
171in 2025
2007high 284 (2021) · low 31 (2013)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LJS
5in 2023
2007high 40 (2012) · low 0 (2007)2026
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · LJS
4,372in 2025
2007high 4,372 (2025) · low 369 (2008)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?
Catheter stylets provide internal reinforcement to aid in catheter placement. The SherlockTM TLS Stylet contains passive magnets that generate a magnetic field. This field can be detected by the Sherlock T M TLS Detector to provide the placer rapid feedback on catheter tip location.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063240 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063240: Sherlock TLS Stylet, Sherlock TLS Detector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063240
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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