510(k) · Cleared
ClearedSapiens Tip 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 Oct 20, 2011 as substantially equivalent to K093775 (Romedex International Srl, 2010) after a 29-day review. Its family tree reaches back 9 generations to 2000. 7 later devices descend from it.
- Decided
- Oct 20, 2011
- Review
- 29 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K001901 (2000). 32 ancestors in all, the oldest K823434 (1982). 7 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 5 generations between
- 3 generations backK081625 Flowpicc StyletVasonova, Inc. · 2008
- 2 generations backK091324 Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning…C.R. Bard, Inc. · 2009 · Recalled
- 1 generation backK093775 Evguide Tip Location SystemRomedex International Srl · 2010
- This deviceK112744 Sapiens Tip Confirmation SystemC.R. Bard, Inc. · 2011
- Descendant · cites it directly · 6 of its ownK113808 The Sherlock 3CG Tip Confirmation System (TCS)C.R. Bard, Inc. · 2012
- Descendant · 2 generations on · 4 of its ownK141634 Nautilus DeltaRomedex International Srl · 2015
- Descendant · 3 generations on · 2 of its ownK241910 Neonav ECG Tip Location SystemNavi Medical Technologies · 2025
- Descendant · 2 generations on · 2 of its ownK140345 The Sherlock 3CG Tip Confirmation System (TCS)C.R. Bard, Inc. · 2014
- Descendant · 3 generations on · 1 of its ownK180560 Sherlock 3CG+ T ip Confirmation SystemC.R. Bard, Inc. · 2018
Show all 9 generations
- Root · 9 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 8 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 7 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 6 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 5 generations backK060341 Sherlock Tip Location System (TLS)C.R. Bard, Inc. · 2006
- 4 generations backK063240 Sherlock TLS Stylet, Sherlock TLS DetectorC.R. Bard, Inc. · 2006 · Recalled
- 3 generations backK081625 Flowpicc StyletVasonova, Inc. · 2008
- 2 generations backK091324 Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning…C.R. Bard, Inc. · 2009 · Recalled
- 1 generation backK093775 Evguide Tip Location SystemRomedex International Srl · 2010
- This deviceK112744 Sapiens Tip Confirmation SystemC.R. Bard, Inc. · 2011
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K113808The Sherlock 3CG Tip Confirmation System (TCS)C.R. Bard, Inc. · 2012 · cites it directly6descendants
- K141634Nautilus DeltaRomedex International Srl · 2015 · 2 generations on4descendants
- K241910Neonav ECG Tip Location SystemNavi Medical Technologies · 2025 · 3 generations on2descendants
- K140345The Sherlock 3CG Tip Confirmation System (TCS)C.R. Bard, Inc. · 2014 · 2 generations on2descendants
- K180560Sherlock 3CG+ T ip Confirmation SystemC.R. Bard, Inc. · 2018 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −8 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −7 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −6 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −5 | K060341 | Sherlock Tip Location System (TLS) | C.R. Bard, Inc. | 2006 | — |
| −4 | K063240 | Sherlock TLS Stylet, Sherlock TLS Detector | C.R. Bard, Inc. | 2006 | 18 |
| −3 | K081625 | Flowpicc Stylet | Vasonova, Inc. | 2008 | — |
| −2 | K091324 | Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System Stylet | C.R. Bard, Inc. | 2009 | 11 |
| −1 | K093775 | Evguide Tip Location System | Romedex International Srl | 2010 | — |
| 0 (this device) | K112744 | Sapiens Tip Confirmation System | C.R. Bard, Inc. | 2011 | — |
| +1 | K113808 | The Sherlock 3CG Tip Confirmation System (TCS) | C.R. Bard, Inc. | 2012 | — |
| +2 | K141634 | Nautilus Delta | Romedex International Srl | 2015 | — |
| +3 | K241910 | Neonav ECG Tip Location System | Navi Medical Technologies | 2025 | — |
| +2 | K140345 | The Sherlock 3CG Tip Confirmation System (TCS) | C.R. Bard, Inc. | 2014 | — |
| +3 | K180560 | Sherlock 3CG+ T ip Confirmation System | C.R. Bard, Inc. | 2018 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2025 | 2 | 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.
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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K093775 | Evguide Tip Location SystemSummary page 1…- Accessory to percutaneous, implanted, long- term Intravascular catheters Premarket Notification: K093775, concurrence date 15 July 2010 Manufacturer: Bard Access Systems, Inc. Device The… | 2010 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113808 | The Sherlock 3CG Tip Confirmation System (TCS) | 2012 | 6 |
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 11 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- 7 of the 32 ancestors have a recall of any class.
- Of its descendants, K113808 (C.R. Bard, Inc., 2012) has gone furthest, with 6 descendants of its own.
- 4 other devices also cite its predicate K093775.
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. 2011, 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 t Tip Confirmation System (TICS) is indicated for guidance and positioning of Peripherally Inserted Central Catheters (PIOCs). The Sapiens* TCS provides real-time P1CC tip location information by using the patient's cardiac electrical activity. Sapiens* TCS is indicated for use as an alternative method to chest X-ray and fluoroscopy for P1CC tip placement confirmation in adult patients. Limiting but not contraindicated situations for this…
Read the full statement (117 words)
The Sapiens t Tip Confirmation System (TICS) is indicated for guidance and positioning of Peripherally Inserted Central Catheters (PIOCs). The Sapiens* TCS provides real-time P1CC tip location information by using the patient's cardiac electrical activity. Sapiens* TCS is indicated for use as an alternative method to chest X-ray and fluoroscopy for P1CC 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. In such patients, who are easily identifiable prior to P1CC 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/K112744 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112744: Sapiens Tip 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/K112744
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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