510(k) · Cleared
ClearedSherlock Tip Location System (TLS) Detector and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lucent Medical Systems · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Jun 2, 2006 after a 30-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 6 of the 44 devices in its family, counting itself, have a Class I recall. 43 later devices descend from it.
- Decided
- Jun 2, 2006
- Review
- 30 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 1
43 later devices descend from it, 2 citing it directly. 6 of the 44 devices in this family, counting this one, have a Class I recall.
- This deviceK061240 Sherlock Tip Location System (TLS) Detector and AccessoriesLucent Medical Systems · 2006
- Descendant · cites it directly · 42 of its ownK063240 Sherlock TLS Stylet, Sherlock TLS DetectorC.R. Bard, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 40 of its ownK081625 Flowpicc StyletVasonova, Inc. · 2008
- Descendant · 2 generations on · 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
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K122545 CG+ Arrow Picc Powered by Arrow VPS Stylet4 generations on · 2012
- K132133 CG+ Arrow Jacc Powered by Arrow VPS Stylet4 generations on · 2013
- K130876 CG+ Arrow Picc Powered by Arrow VPS Stylet5 generations on · 2013
- K153423 CG+ Arrow JACC powered by Arrow VPS Stylet, CG+…5 generations on · 2016
Most influential descendants
Showing 5 of 43 · See all- K063240Sherlock TLS Stylet, Sherlock TLS DetectorC.R. Bard, Inc. · 2006 · cites it directly42descendants
- K081625Flowpicc StyletVasonova, Inc. · 2008 · 2 generations on40descendants
- K081626Flowpicc ConsoleVasonova, Inc. · 2008 · 2 generations on39descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061240 | Sherlock Tip Location System (TLS) Detector and Accessories | Lucent Medical Systems | 2006 | — |
| +1 | K063240 | Sherlock TLS Stylet, Sherlock TLS Detector | C.R. Bard, Inc. | 2006 | 18 |
| +2 | K081625 | Flowpicc Stylet | Vasonova, Inc. | 2008 | — |
| +2 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K000099 | FDA’s K000099 is Camlog Screw Implant System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2000 |
What descends from it? (43)
See all 432 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)
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.
- K122545CG+ Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2012 · 4 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 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K130876CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. · 2013 · 5 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 · 5 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 · 5 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?
- Of its descendants, K063240 (C.R. Bard, Inc., 2006) has gone furthest, with 42 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
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 SherlockTM Tip Location System (TLS) Detector quickly locates and confirms the position of specially designed, magnet-tipped Peripherally-Inserted Central Catheters (PICCs) and Central Venous Catheters (CVCs) during initial placement. This device may be used by appropriate caregivers in hospitals, long-term care facilities or home-care settings.
The SherlockTM Tip Location System (TLS) Detector provides rapid feedback to the caregiver, but was not designed to replace conventional methods of placement verification. Users are urged to confirm correct placement according to their established institutional protocol and clinical judgment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061240 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061240: Sherlock Tip Location System (TLS) Detector and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061240
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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