510(k) · Cleared
ClearedEvguide Tip Location System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Romedex International Srl · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Jul 15, 2010 as substantially equivalent to K091324 (C.R. Bard, Inc., 2009) and 2 other predicates after a 219-day review. Its family tree reaches back 8 generations to 2000. 6 of the 66 devices in its family, counting itself, have a Class I recall. 34 later devices descend from it.
- Decided
- Jul 15, 2010
- Review
- 219 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K001901 (2000). 31 ancestors in all, the oldest K823434 (1982). 34 later devices descend from it, 5 citing it directly. 6 of the 66 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 7 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 6 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 5 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 4 generations backK060341 Sherlock Tip Location System (TLS)C.R. Bard, Inc. · 2006
- 3 generations backK063240 Sherlock TLS Stylet, Sherlock TLS DetectorC.R. Bard, Inc. · 2006 · Recalled
- 2 generations backK081625 Flowpicc StyletVasonova, Inc. · 2008
- 1 generation backK091324 Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning…C.R. Bard, Inc. · 2009 · Recalled
- This deviceK093775 Evguide Tip Location SystemRomedex International Srl · 2010
- Descendant · cites it directly · 13 of its ownK140799 Celerity SysyemMedcomp (Medical Components, Inc.) · 2014 · Recalled
- Descendant · cites it directly · 10 of its ownK103255 Vascular Positioning System TM (VPS TM System) StyletVasonova, Inc. · 2011 · Recalled
- Descendant · cites it directly · 8 of its ownK142889 Celerity PICC Tip Confirmation SystemAngioDynamics, Inc. · 2015 · Recalled
- Descendant · cites it directly · 7 of its ownK112744 Sapiens Tip Confirmation SystemC.R. Bard, Inc. · 2011
- Descendant · 2 generations on · 6 of its ownK113808 The Sherlock 3CG Tip Confirmation System (TCS)C.R. Bard, Inc. · 2012
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K122545 CG+ Arrow Picc Powered by Arrow VPS Stylet2 generations on · 2012
- K132133 CG+ Arrow Jacc Powered by Arrow VPS Stylet2 generations on · 2013
- K130876 CG+ Arrow Picc Powered by Arrow VPS Stylet3 generations on · 2013
- K153423 CG+ Arrow JACC powered by Arrow VPS Stylet, CG+…3 generations on · 2016
Most influential descendants
Showing 5 of 34 · See all- K140799Celerity SysyemMedcomp (Medical Components, Inc.) · 2014 · cites it directly13descendants
- K103255Vascular Positioning System TM (VPS TM System) StyletVasonova, Inc. · 2011 · cites it directly10descendants
- K142889Celerity PICC Tip Confirmation SystemAngioDynamics, Inc. · 2015 · cites it directly8descendants
- K112744Sapiens Tip Confirmation SystemC.R. Bard, Inc. · 2011 · cites it directly7descendants
- K113808The Sherlock 3CG Tip Confirmation System (TCS)C.R. Bard, Inc. · 2012 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −7 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −6 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −5 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −4 | K060341 | Sherlock Tip Location System (TLS) | C.R. Bard, Inc. | 2006 | — |
| −3 | K063240 | Sherlock TLS Stylet, Sherlock TLS Detector | C.R. Bard, Inc. | 2006 | 18 |
| −2 | K081625 | Flowpicc Stylet | Vasonova, Inc. | 2008 | — |
| −1 | K091324 | Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System Stylet | C.R. Bard, Inc. | 2009 | 11 |
| 0 (this device) | K093775 | Evguide Tip Location System | Romedex International Srl | 2010 | — |
| +1 | K140799 | Celerity Sysyem | Medcomp (Medical Components, Inc.) | 2014 | 1 |
| +1 | K103255 | Vascular Positioning System TM (VPS TM System) Stylet | Vasonova, Inc. | 2011 | 4 |
| +1 | K142889 | Celerity PICC Tip Confirmation System | AngioDynamics, Inc. | 2015 | 1 |
| +1 | K112744 | Sapiens Tip Confirmation System | C.R. Bard, Inc. | 2011 | — |
| +2 | K113808 | The Sherlock 3CG Tip Confirmation System (TCS) | C.R. Bard, Inc. | 2012 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 0 |
| 2012 | 3 | 1 |
| 2013 | 4 | 2 |
| 2014 | 3 | 0 |
| 2015 | 5 | 0 |
| 2016 | 4 | 3 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K091324 | Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System StyletSummary page 1…dex.com, www.romedex.com Sorin Grunwald Ph.D.. MBA, 175 Colorado Ave, Palo Alto, CA 94303, sorin @romedex.com, Tel: +1.650.209.4838, Fax: +1.650.887.0348 June 4. 2010 K091324 - Sherlock 3CG Tip Positioning System K032613 - Transvenous Pacemaker Placement Assist Device K973371 - Conduction Anesthesia Ki… | 2009 |
| * | K032613 | Temporary Transvenous Pacemaker Placement Assist DeviceSummary page 1…MBA, 175 Colorado Ave, Palo Alto, CA 94303, sorin @romedex.com, Tel: +1.650.209.4838, Fax: +1.650.887.0348 June 4. 2010 K091324 - Sherlock 3CG Tip Positioning System K032613 - Transvenous Pacemaker Placement Assist Device K973371 - Conduction Anesthesia Kit K843263 - Arrow-Johans ECG Adaptor The Sapi… | 2003 |
| Kept off the family tree | K973371 | FDA’s K973371 is Certodyn Raecg Universal Adapter Our OCR of the scanned summary read K973371, FDA’s number for Certodyn Raecg Universal Adapter (B.Braun Medical, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Conduction Anesthesia Kit”. Kept off the family tree. Summary page 1…dex.com, Tel: +1.650.209.4838, Fax: +1.650.887.0348 June 4. 2010 K091324 - Sherlock 3CG Tip Positioning System K032613 - Transvenous Pacemaker Placement Assist Device K973371 - Conduction Anesthesia Kit K843263 - Arrow-Johans ECG Adaptor The Sapiens™ Tip Location System (TLS) is indicated for guidance… | 1997 |
| * | K843263 | Arrow-Johans Ecg AdaptorSummary page 1…1.650.887.0348 June 4. 2010 K091324 - Sherlock 3CG Tip Positioning System K032613 - Transvenous Pacemaker Placement Assist Device K973371 - Conduction Anesthesia Kit K843263 - Arrow-Johans ECG Adaptor The Sapiens™ Tip Location System (TLS) is indicated for guidance and positioning of central venous ca… | 1984 |
What descends from it? (34)
See all 345 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 · 2 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 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K130876CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. · 2013 · 3 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 · 3 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 · 3 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 · 3 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 10 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- 7 of the 31 ancestors have a recall of any class.
- Of its descendants, K140799 (Medcomp (Medical Components, Inc.), 2014) has gone furthest, with 13 descendants of its own.
- 3 other devices also cite its predicate K091324.
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. 2010, 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 Sapiens™ Tip Location System (TLS) is indicated for guidance and positioning of central venous catheters such as PICCs, CVCs, implantable ports, and hemodialysis catheters. The Sapiens™ TLS provides real-time catheter tip location information by using the patient’s cardiac electrical activity. Sapiens™ TLS is indicated for use as an alternative method to chest X-ray and fluoroscopy for central venous catheter tip placement confirmation in adult…
Read the full statement (148 words)
The Sapiens™ Tip Location System (TLS) is indicated for guidance and positioning of central venous catheters such as PICCs, CVCs, implantable ports, and hemodialysis catheters. The Sapiens™ TLS provides real-time catheter tip location information by using the patient’s cardiac electrical activity. Sapiens™ TLS is indicated for use as an alternative method to chest X-ray and fluoroscopy for central venous catheter tip placement confirmation in adult patients.
Limiting but not contraindicated situations for this technique 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, and in central venous catheterization procedures performed through femoral or saphaneous vein access which change the presentation of the P wave. In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional method is required to confirm catheter tip location.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K093775 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093775: Evguide Tip Location System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093775
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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