510(k) · Cleared
ClearedSherlock Tip Location System (TLS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Apr 14, 2006 as substantially equivalent to K023374 (C.R. Bard, Inc., 2002) and 3 other predicates after a 63-day review. Its family tree reaches back 4 generations to 2000. 6 of the 53 devices in its family, counting itself, have a Class I recall. 43 later devices descend from it.
- Decided
- Apr 14, 2006
- Review
- 63 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K001901 (2000). 9 ancestors in all, the oldest K904558 (1991). 43 later devices descend from it, 1 citing it directly. 6 of the 53 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 3 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 2 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 1 generation backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- This deviceK060341 Sherlock Tip Location System (TLS)C.R. Bard, Inc. · 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 · 2 generations on · 38 of its ownK091324 Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning…C.R. Bard, Inc. · 2009 · Recalled
- Descendant · 3 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 · 2 generations on38descendants
- K093775Evguide Tip Location SystemRomedex International Srl · 2010 · 3 generations on34descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −3 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −2 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −1 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| 0 (this device) | K060341 | Sherlock Tip Location System (TLS) | C.R. Bard, Inc. | 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 | — |
| +2 | K091324 | Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System Stylet | C.R. Bard, Inc. | 2009 | 11 |
| +3 | K093775 | Evguide Tip Location System | Romedex International Srl | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
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 FOZ device
- #1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 8 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 |
|---|---|---|---|
| * | K023374 | Groshong NXT Dual Lumen Picc CathetersSummary page 1…21 CFR 880.5970- Class 11 Classification Panel: General Hospital 5 Fr DL Groshong® nXt PICC Catheter K023374 12/18/2002 Poly Per-Q-Cath® PICC K034019 1/21/2004… | 2002 |
| * | K034019 | Poly Per-Q-Cath Picc CathetersSummary page 1…spital 5 Fr DL Groshong® nXt PICC Catheter K023374 12/18/2002 Poly Per-Q-Cath® PICC K034019 1/21/2004 0000169 === Page… | 2004 |
| * | K935380 | Vascular Access Catheter AccessoriesSummary page 2…eav CleahrnceDate i Sensor Stylet and Sensor Guidewire K935380 2/17/1995 Device Name: Zortran Detector Trade Name: Zortran Detector… | 1995 |
| * | K000997 | Zortran DetectorSummary page 2…21 CFR 880.5970- Class II Classification Panel: General Hospital Zortran Detector K000997 9/7/2000 5.4 Intended Use The intended use of the subject device is the same as the intended use of the p… | 2000 |
What descends from it? (43)
See all 431 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063240 | Sherlock TLS Stylet, Sherlock TLS Detector | 2006 | 42 |
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 · 6 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 6 years and passes through 1 company; a new generation was cleared every 1.6 years on median.
- 4 of the 9 ancestors have a recall of any class.
- Of its descendants, K063240 (C.R. Bard, Inc., 2006) has gone furthest, with 42 descendants of its own.
- 2 other devices also cite its predicate K023374.
How does its category compare?
All FOZ devicesFOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FOZ
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FOZ
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FOZ
4in 2023
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · FOZ
5,110in 2025
MAUDE reports naming product code FOZ, 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 | 6 | 159 | 16 | 374 |
| 2008 | 9 | 103 | 0 | 422 |
| 2009 | 9 | 30 | 23 | 508 |
| 2010 | 3 | 28 | 115 | 370 |
| 2011 | 6 | 132 | 0 | 786 |
| 2012 | 13 | 122 | 0 | 560 |
| 2013 | 4 | 104 | 2 | 640 |
| 2014 | 9 | 99 | 4 | 815 |
| 2015 | 10 | 107 | 0 | 729 |
| 2016 | 9 | 63 | 3 (1) | 925 |
| 2017 | 9 | 51 | 22 | 1,966 |
| 2018 | 1 | — | 4 | 3,305 |
| 2019 | 8 | 140 | 3 | 4,365 |
| 2020 | 10 | 191 | 3 | 3,797 |
| 2021 | 4 | 242 | 1 | 4,674 |
| 2022 | 8 | 183 | 4 (2) | 4,133 |
| 2023 | 9 | 129 | 4 (2) | 4,430 |
| 2024 | 6 | 190 | 0 | 4,772 |
| 2025 | 11 | 91 | 0 | 5,110 |
| 2026 | 7 | 203 | 2 | — |
What is it indicated for?
Catheter stylets provide internal reinforcement to aid in catheter placement. The Sherlock TLS Stylet contains passive magnets that generate a magnetic field. This field can be detected by the Sherlock TLS Detector to provide the placer rapid feedback on catheter tip location.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060341 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060341: Sherlock Tip Location System (TLS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060341
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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