510(k) · Cleared
Recalled · Class II · 2026Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System Stylet
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 Aug 7, 2009 as substantially equivalent to K061240 (Lucent Medical Systems, 2006) and 3 other predicates after a 94-day review. Its family tree reaches back 7 generations to 2000. 6 of the 67 devices in its family, counting itself, have a Class I recall. 38 later devices descend from it. It has been recalled 11 times.
- Decided
- Aug 7, 2009
- Review
- 94 days
- Class
- Class II
- Product code
- LJS
- Recalls
- 11
- Predicates
- 4
Its longest line of descent runs back 7 generations to K001901 (2000). 28 ancestors in all, the oldest K823434 (1982). 38 later devices descend from it, 4 citing it directly. 6 of the 67 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 6 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 5 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 4 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 3 generations backK060341 Sherlock Tip Location System (TLS)C.R. Bard, Inc. · 2006
- 2 generations backK063240 Sherlock TLS Stylet, Sherlock TLS DetectorC.R. Bard, Inc. · 2006 · Recalled
- 1 generation backK081625 Flowpicc StyletVasonova, Inc. · 2008
- This deviceK091324 Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning…C.R. Bard, Inc. · 2009
- Descendant · cites it directly · 34 of its ownK093775 Evguide Tip Location SystemRomedex International Srl · 2010
- Descendant · 2 generations on · 13 of its ownK140799 Celerity SysyemMedcomp (Medical Components, Inc.) · 2014 · Recalled
- Descendant · 2 generations on · 10 of its ownK103255 Vascular Positioning System TM (VPS TM System) StyletVasonova, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 8 of its ownK142889 Celerity PICC Tip Confirmation SystemAngioDynamics, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 7 of its ownK112744 Sapiens Tip Confirmation SystemC.R. Bard, Inc. · 2011
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
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 38 · See all- K093775Evguide Tip Location SystemRomedex International Srl · 2010 · cites it directly34descendants
- K140799Celerity SysyemMedcomp (Medical Components, Inc.) · 2014 · 2 generations on13descendants
- K103255Vascular Positioning System TM (VPS TM System) StyletVasonova, Inc. · 2011 · 2 generations on10descendants
- K142889Celerity PICC Tip Confirmation SystemAngioDynamics, Inc. · 2015 · 2 generations on8descendants
- K112744Sapiens Tip Confirmation SystemC.R. Bard, Inc. · 2011 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −6 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −5 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −4 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −3 | K060341 | Sherlock Tip Location System (TLS) | C.R. Bard, Inc. | 2006 | — |
| −2 | K063240 | Sherlock TLS Stylet, Sherlock TLS Detector | C.R. Bard, Inc. | 2006 | 18 |
| −1 | K081625 | Flowpicc Stylet | Vasonova, Inc. | 2008 | — |
| 0 (this device) | K091324 | Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System Stylet | C.R. Bard, Inc. | 2009 | — |
| +1 | K093775 | Evguide Tip Location System | Romedex International Srl | 2010 | — |
| +2 | K140799 | Celerity Sysyem | Medcomp (Medical Components, Inc.) | 2014 | 1 |
| +2 | K103255 | Vascular Positioning System TM (VPS TM System) Stylet | Vasonova, Inc. | 2011 | 4 |
| +2 | K142889 | Celerity PICC Tip Confirmation System | AngioDynamics, Inc. | 2015 | 1 |
| +2 | K112744 | Sapiens Tip Confirmation System | C.R. Bard, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 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 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | K061240 | Sherlock Tip Location System (TLS) Detector and AccessoriesSummary page 1….] 605 North 5600 West, Salt Lake City, UT 84116 (801) 522-0700, x5432 Predicate devices: K061240 - Sherlock T M 11Tip Location System Detector K063240 - SherlockT M Tip Location System Stylet… | 2006 |
| * | K063240 | Sherlock TLS Stylet, Sherlock TLS DetectorSummary page 1…(801) 522-0700, x5432 Predicate devices: K061240 - Sherlock T M 11Tip Location System Detector K063240 - SherlockT M Tip Location System Stylet K081626 - FlowPICC TM Console… | 2006 |
| * | K081626 | Flowpicc ConsoleSummary page 1…K061240 - Sherlock T M 11Tip Location System Detector K063240 - SherlockT M Tip Location System Stylet K081626 - FlowPICC TM Console K081625 - FlowPICC TM Stylet Performance Performance… | 2008 |
| * | K081625 | Flowpicc StyletSummary page 1…K063240 - SherlockT M Tip Location System Stylet K081626 - FlowPICC TM Console K081625 - FlowPICC TM Stylet Performance Performance standards have not been established by the FDA under Standards:… | 2008 |
What descends from it? (38)
See all 384 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 |
|---|---|---|---|---|
| May 21, 2026 | Class II | Z-2658-2026 | Nonconforming Material/Component | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. |
| Feb 26, 2020 | Class II | Z-2077-2020 | Under Investigation by firm | The kits contain surgical gowns which were subject to a recall by the supplier. |
| Feb 26, 2020 | Class II | Z-2079-2020 | Under Investigation by firm | The kits contain surgical gowns which were subject to a recall by the supplier. |
| Feb 26, 2020 | Class II | Z-2082-2020 | Under Investigation by firm | The kits contain surgical gowns which were subject to a recall by the supplier. |
| Feb 26, 2020 | Class II | Z-2075-2020 | Under Investigation by firm | The kits contain surgical gowns which were subject to a recall by the supplier. |
| Feb 26, 2020 | Class II | Z-2076-2020 | Under Investigation by firm | The kits contain surgical gowns which were subject to a recall by the supplier. |
| Feb 26, 2020 | Class II | Z-2078-2020 | Under Investigation by firm | The kits contain surgical gowns which were subject to a recall by the supplier. |
| May 27, 2015 | Class III | Z-2049-2015 | Labeling Change Control | Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling. |
| May 27, 2015 | Class III | Z-2048-2015 | Labeling Change Control | Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling. |
| May 27, 2015 | Class III | Z-2047-2015 | Labeling Change Control | Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling. |
| May 27, 2015 | Class III | Z-2050-2015 | Labeling Change Control | Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling. |
The 5 latest of 11 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 · 4 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 9 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 5 of the 28 ancestors have a recall of any class.
- Of its descendants, K093775 (Romedex International Srl, 2010) has gone furthest, with 34 descendants of its own.
- 1 other device also cites its predicate K061240.
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. 2009, 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?
Catheter stylets provide internal reinforcement to aid in catheter placement. When used with the Sherlock 3CG TM Tip Positioning System (TPS), the Sherlock 3CG TM TPS Stylet also provides the placer rapid feedback on catheter tip location and orientation through the use of passive magnets and cardiac electrical signal detection.
The Sherlock 3CG TM Tip Positioning System (TPS) is indicated for central venous catheter guidance and positioning during catheter placement. The Sherlock 3CG TM TPS provides real time catheter tip location information through the use of passive magnet and cardiac electrical signal detection.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091324 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091324: Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System Stylet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091324
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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