510(k) · Cleared
ClearedSherlock 3CG+ T ip Confirmation System
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 Jun 18, 2018 as substantially equivalent to K141634 (Romedex International Srl, 2015) and 1 other predicate after a 109-day review. Its family tree reaches back 12 generations to 2000. 1 later device descends from it.
- Decided
- Jun 18, 2018
- Review
- 109 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K001901 (2000). 36 ancestors in all, the oldest K823434 (1982). 1 later device descends from it, 1 citing it directly.
- 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 backK112744 Sapiens Tip Confirmation SystemC.R. Bard, Inc. · 2011
- 2 generations backK113808 The Sherlock 3CG Tip Confirmation System (TCS)C.R. Bard, Inc. · 2012
- 1 generation backK140345 The Sherlock 3CG Tip Confirmation System (TCS)C.R. Bard, Inc. · 2014
- This deviceK180560 Sherlock 3CG+ T ip Confirmation SystemC.R. Bard, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK252792 PM2™ System with ECGuide™ ConnectorPiccolo Medical, Inc. · 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 backK112744 Sapiens Tip Confirmation SystemC.R. Bard, Inc. · 2011
- 2 generations backK113808 The Sherlock 3CG Tip Confirmation System (TCS)C.R. Bard, Inc. · 2012
- 1 generation backK140345 The Sherlock 3CG Tip Confirmation System (TCS)C.R. Bard, Inc. · 2014
- This deviceK180560 Sherlock 3CG+ T ip Confirmation SystemC.R. Bard, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K252792PM2™ System with ECGuide™ ConnectorPiccolo Medical, Inc. · 2025 · cites it directly0descendants
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 | K112744 | Sapiens Tip Confirmation System | C.R. Bard, Inc. | 2011 | — |
| −2 | K113808 | The Sherlock 3CG Tip Confirmation System (TCS) | C.R. Bard, Inc. | 2012 | — |
| −1 | K140345 | The Sherlock 3CG Tip Confirmation System (TCS) | C.R. Bard, Inc. | 2014 | — |
| 0 (this device) | K180560 | Sherlock 3CG+ T ip Confirmation System | C.R. Bard, Inc. | 2018 | — |
| +1 | K252792 | PM2™ System with ECGuide™ Connector | Piccolo Medical, Inc. | 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 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (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 |
|---|---|---|---|
| * | K141634 | Nautilus DeltaSummary page 4…Number: 21 CFR 880.5970 FDA Product Code: LJS 3. Predicate Device(s) and Reference Device(s) Primary Predicate Device 510(k) Number: K141634 Name of Device: Nautilus Delta Common or Usual Name: Nautilus Delta Owner/Manufacturer: Bard Access… | 2015 |
| * | K140345 | The Sherlock 3CG Tip Confirmation System (TCS)Summary page 4…egulatory Class: Class II Regulation Number: 21 CFR 880.5970 FDA Product Code: LJS Secondary Predicate Device 510(k) Number: K140345 Name of Device: SHERLOCK 3CG™ Tip Confirmation System (TCS) Common or Usual Name: SHERLOCK 3CG™ Tip Confirmation… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252792 | PM2™ System with ECGuide™ Connector | 2025 | 0 |
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 18 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 7 of the 36 ancestors have a recall of any class.
- Of its descendants, K252792 (Piccolo Medical, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K141634.
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 Sherlock 3CG+™ Tip Confirmation System (TCS) is indicated for navigation and positioning of central venous access devices (CVADs) of at least 2 Fr in size. The Sherlock 3CG+™ TCS provides real-time catheter tip location information by using catheter navigation technology along with the patient's cardiac electrical activity and is indicated for use as an alternative method to chest X-ray and fluoroscopy for CVAD tip placement confirmation of…
Read the full statement (246 words)
The Sherlock 3CG+™ Tip Confirmation System (TCS) is indicated for navigation and positioning of central venous access devices (CVADs) of at least 2 Fr in size. The Sherlock 3CG+™ TCS provides real-time catheter tip location information by using catheter navigation technology along with the patient's cardiac electrical activity and is indicated for use as an alternative method to chest X-ray and fluoroscopy for CVAD tip placement confirmation of approaches from the superior vena cava.
In adult patients and in adolescents (greater than 12 through 21 years of age), the Sherlock 3CG+™ TCS can be used with CVADs such as peripherally inserted central catheters (PICCs), central venous catheters (CVCs), implantable ports, and hemodialysis catheters; in children (greater than 2 to 12 years of age), in infants (greater than 1 month to 2 years of age), and in neonates (from birth to 1 month of age), the Sherlock 3CG+™ TCS can be used with PICCs and with centrally inserted central catheters (CICCs). In each specific age group, the CVAD type and size must be chosen and the CVAD must be used according to the CVAD’s indications and instructions for use.
Limiting but not contraindicated situations for this method are in patients where alterations of cardiac rhythm change the presentation of the P-wave as in atrial fibrillation, atrial flutter, severe tachycardia, and pacemaker driven rhythm. In such patients, who are easily identifiable prior to catheter insertion, the use of an additional method is required to confirm catheter tip location.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180560 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180560: Sherlock 3CG+ T ip Confirmation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180560
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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