510(k) · Cleared
Recalled · Class I · 2023VPS Rhythm Device with TipTracker Technology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow International, Inc. (A Subsidiary of Teleflex, Inc.) · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Dec 22, 2016 as substantially equivalent to K152261 (Nostix, LLC, 2015) after a 262-day review. Its family tree reaches back 12 generations to 2000. 1 of the 40 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it. It has been recalled 7 times, including a Class I recall.
- Decided
- Dec 22, 2016
- Review
- 262 days
- Class
- Class II
- Product code
- LJS
- Recalls
- 7 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 12 generations to K001901 (2000). 35 ancestors in all, the oldest K823434 (1982). 4 later devices descend from it, 2 citing it directly. 1 of the 40 devices in this family, counting this one, has a Class I recall.
- 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 backK140799 Celerity SysyemMedcomp (Medical Components, Inc.) · 2014 · Recalled
- 2 generations backK142889 Celerity PICC Tip Confirmation SystemAngioDynamics, Inc. · 2015 · Recalled
- 1 generation backK152261 PICC Tip Positioning AidNostix, LLC · 2015
- This deviceK160925 VPS Rhythm Device with TipTracker TechnologyArrow International, Inc. (A Subsidiary of Teleflex, Inc.) · 2016
- Descendant · cites it directly · 2 of its ownK240486 PM2 System and ECGuide ConnectorPiccolo Medical, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK252792 PM2™ System with ECGuide™ ConnectorPiccolo Medical, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK243484 PM2+ System and SmartPICC StyletPiccolo Medical, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK220363 VPS Rhythm DLX Device with TipTracker TechnologyArrow International, LLC (A subsidiary of Teleflex, Inc.) · 2022
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 backK140799 Celerity SysyemMedcomp (Medical Components, Inc.) · 2014 · Recalled
- 2 generations backK142889 Celerity PICC Tip Confirmation SystemAngioDynamics, Inc. · 2015 · Recalled
- 1 generation backK152261 PICC Tip Positioning AidNostix, LLC · 2015
- This deviceK160925 VPS Rhythm Device with TipTracker TechnologyArrow International, Inc. (A Subsidiary of Teleflex, Inc.) · 2016
Most influential descendants
Showing 4 of 4 · See all- K240486PM2 System and ECGuide ConnectorPiccolo Medical, Inc. · 2024 · cites it directly2descendants
- K252792PM2™ System with ECGuide™ ConnectorPiccolo Medical, Inc. · 2025 · 2 generations on0descendants
- K243484PM2+ System and SmartPICC StyletPiccolo Medical, Inc. · 2025 · 2 generations on0descendants
- K220363VPS Rhythm DLX Device with TipTracker TechnologyArrow International, LLC (A subsidiary of Teleflex, Inc.) · 2022 · 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 | K140799 | Celerity Sysyem | Medcomp (Medical Components, Inc.) | 2014 | 1 |
| −2 | K142889 | Celerity PICC Tip Confirmation System | AngioDynamics, Inc. | 2015 | 1 |
| −1 | K152261 | PICC Tip Positioning Aid | Nostix, LLC | 2015 | — |
| 0 (this device) | K160925 | VPS Rhythm Device with TipTracker Technology | Arrow International, Inc. (A Subsidiary of Teleflex, Inc.) | 2016 | — |
| +1 | K240486 | PM2 System and ECGuide Connector | Piccolo Medical, Inc. | 2024 | — |
| +2 | K252792 | PM2™ System with ECGuide™ Connector | Piccolo Medical, Inc. | 2025 | — |
| +2 | K243484 | PM2+ System and SmartPICC Stylet | Piccolo Medical, Inc. | 2025 | — |
| +1 | K220363 | VPS Rhythm DLX Device with TipTracker Technology | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | 2022 | — |
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 |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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.
1 device in this family has 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? (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 |
|---|---|---|---|
| * | K152261 | PICC Tip Positioning AidSummary page 4…Reference Device(s): Predicate or Reference Device Name 510(k) Original Applicant Name PICC Tip Positioning Aid K152261 Nostix LLC Sherlock 3CG™ Tip Confirmation System K140345 Bard Access Systems, Inc. Nautilus Delta… | 2015 |
| † | K140345 | The Sherlock 3CG Tip Confirmation System (TCS) | 2014 |
| † | K141634 | Nautilus Delta | 2015 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 10, 2023 | Class I | Z-0004-2024 | Under Investigation by firm | This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits. |
| May 17, 2018 | Class II | Z-2383-2018 | Labeling False and Misleading | Product pouch label may not easily identify the lot number, expiration date and associated symbols.. |
| May 17, 2018 | Class II | Z-2384-2018 | Labeling False and Misleading | Product pouch label may not easily identify the lot number, expiration date and associated symbols.. |
| May 17, 2018 | Class II | Z-2382-2018 | Labeling False and Misleading | Product pouch label may not easily identify the lot number, expiration date and associated symbols.. |
| Apr 11, 2018 | Class II | Z-2028-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Apr 11, 2018 | Class II | Z-2026-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Apr 11, 2018 | Class II | Z-2027-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 7 companies; a new generation was cleared every 12 months on median.
- 9 of the 35 ancestors have a recall of any class.
- Of its descendants, K240486 (Piccolo Medical, Inc., 2024) has gone furthest, with 2 descendants of its own.
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. 2016, 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 VPS Rhythm Device is indicated for the positioning of central venous catheters including PICCs. It provides catheter tip location information by using the patient’s cardiac electrical activity. The VPS Rhythm Device is indicated for use as an alternative method to chest x-ray or fluoroscopy for confirmation of central venous catheter tip placement in adult patients. The TipTracker Technology is an optional accessory for use with the VPS Rhythm…
Read the full statement (181 words)
The VPS Rhythm Device is indicated for the positioning of central venous catheters including PICCs. It provides catheter tip location information by using the patient’s cardiac electrical activity. The VPS Rhythm Device is indicated for use as an alternative method to chest x-ray or fluoroscopy for confirmation of central venous catheter tip placement in adult patients. The TipTracker Technology is an optional accessory for use with the VPS Rhythm Device, indicated for visual navigation of a peripherally-inserted central catheter (PICC) as it is inserted through the vasculature. The TipTracker technology is used for catheter tip navigation purposes only; it is not used to determine final catheter tip placement.
Note: In general, devices that utilize ECG technique to observe P-wave are limited, but not contraindicated, for patients where cardiac rhythms may change presentation of the P-wave; including
- Atrial fibrillation
- Atrial flutter
- Severe tachycardia
- Pacemaker-driven rhythm
- Chronic obstructive pulmonary disease (COPD)
Such patients are easily identified prior to central catheter insertion. In these specific cases, use of an additional confirmation method is necessary to confirm catheter tip location.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160925 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160925: VPS Rhythm Device with TipTracker Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160925
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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