510(k) · Cleared
ClearedPICC Tip Positioning Aid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nostix, LLC · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Oct 21, 2015 as substantially equivalent to K142889 (AngioDynamics, Inc., 2015) after a 71-day review. Its family tree reaches back 11 generations to 2000. 1 of the 40 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Oct 21, 2015
- Review
- 71 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K001901 (2000). 34 ancestors in all, the oldest K823434 (1982). 5 later devices descend from it, 1 citing it directly. 1 of the 40 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 7 generations between
- 3 generations backK093775 Evguide Tip Location SystemRomedex International Srl · 2010
- 2 generations backK140799 Celerity SysyemMedcomp (Medical Components, Inc.) · 2014 · Recalled
- 1 generation backK142889 Celerity PICC Tip Confirmation SystemAngioDynamics, Inc. · 2015 · Recalled
- This deviceK152261 PICC Tip Positioning AidNostix, LLC · 2015
- Descendant · cites it directly · 4 of its ownK160925 VPS Rhythm Device with TipTracker TechnologyArrow International, Inc. (A Subsidiary of Teleflex, Inc.) · 2016 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK240486 PM2 System and ECGuide ConnectorPiccolo Medical, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK252792 PM2™ System with ECGuide™ ConnectorPiccolo Medical, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK243484 PM2+ System and SmartPICC StyletPiccolo Medical, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK220363 VPS Rhythm DLX Device with TipTracker TechnologyArrow International, LLC (A subsidiary of Teleflex, Inc.) · 2022
Show all 11 generations
- Root · 11 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 10 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 9 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 8 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 7 generations backK060341 Sherlock Tip Location System (TLS)C.R. Bard, Inc. · 2006
- 6 generations backK063240 Sherlock TLS Stylet, Sherlock TLS DetectorC.R. Bard, Inc. · 2006 · Recalled
- 5 generations backK081625 Flowpicc StyletVasonova, Inc. · 2008
- 4 generations backK091324 Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning…C.R. Bard, Inc. · 2009 · Recalled
- 3 generations backK093775 Evguide Tip Location SystemRomedex International Srl · 2010
- 2 generations backK140799 Celerity SysyemMedcomp (Medical Components, Inc.) · 2014 · Recalled
- 1 generation backK142889 Celerity PICC Tip Confirmation SystemAngioDynamics, Inc. · 2015 · Recalled
- This deviceK152261 PICC Tip Positioning AidNostix, LLC · 2015
Class I recalls in this family
- K160925 VPS Rhythm Device with TipTracker Technologycites it directly · 2016
Most influential descendants
Showing 5 of 5 · See all- K160925VPS Rhythm Device with TipTracker TechnologyArrow International, Inc. (A Subsidiary of Teleflex, Inc.) · 2016 · cites it directly4descendants
- K240486PM2 System and ECGuide ConnectorPiccolo Medical, Inc. · 2024 · 2 generations on2descendants
- K252792PM2™ System with ECGuide™ ConnectorPiccolo Medical, Inc. · 2025 · 3 generations on0descendants
- K243484PM2+ System and SmartPICC StyletPiccolo Medical, Inc. · 2025 · 3 generations on0descendants
- K220363VPS Rhythm DLX Device with TipTracker TechnologyArrow International, LLC (A subsidiary of Teleflex, Inc.) · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −10 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −9 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −8 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −7 | K060341 | Sherlock Tip Location System (TLS) | C.R. Bard, Inc. | 2006 | — |
| −6 | K063240 | Sherlock TLS Stylet, Sherlock TLS Detector | C.R. Bard, Inc. | 2006 | 18 |
| −5 | K081625 | Flowpicc Stylet | Vasonova, Inc. | 2008 | — |
| −4 | 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 | — |
| −2 | K140799 | Celerity Sysyem | Medcomp (Medical Components, Inc.) | 2014 | 1 |
| −1 | K142889 | Celerity PICC Tip Confirmation System | AngioDynamics, Inc. | 2015 | 1 |
| 0 (this device) | K152261 | PICC Tip Positioning Aid | Nostix, LLC | 2015 | — |
| +1 | K160925 | VPS Rhythm Device with TipTracker Technology | Arrow International, Inc. (A Subsidiary of Teleflex, Inc.) | 2016 | Class I |
| +2 | K240486 | PM2 System and ECGuide Connector | Piccolo Medical, Inc. | 2024 | — |
| +3 | K252792 | PM2™ System with ECGuide™ Connector | Piccolo Medical, Inc. | 2025 | — |
| +3 | K243484 | PM2+ System and SmartPICC Stylet | Piccolo Medical, Inc. | 2025 | — |
| +2 | 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 |
|---|---|---|
| 2016 | 1 | 1 |
| 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 |
|---|---|---|---|
| * | K142889 | Celerity PICC Tip Confirmation SystemSummary page 4…-term intravascular catheter Product Code LJS Regulation 21 CFR 880.5970 Class 2 Predicate Trade Name Celerity System Clearance K142889, 27 January 2015 Common Name PICC placement accessory Class Name Percutaneous, implanted, long-term intravascular ca… | 2015 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160925 | VPS Rhythm Device with TipTracker Technology Class I | 2016 | 4 |
Has anything in its family been recalled? (1 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.
- K160925VPS Rhythm Device with TipTracker TechnologyArrow International, Inc. (A Subsidiary of Teleflex, Inc.) · 2016 · Cites it directly · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 9 of the 34 ancestors have a recall of any class.
- Of its descendants, K160925 (Arrow International, Inc. (A Subsidiary of Teleflex, Inc.), 2016) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K142889.
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. 2015, 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 PICC Tip Positioning Aid is indicated for the positioning of Peripherally Inserted Central Catheters (P1CC) in adult patients. It provides real-time catheter tip location information by using the patient's cardiac electrical activity. The PICC Tip Positioning Aid is indicated for use as an alternative method to chest x-ray or fluoroscopy confirmation of PICC tip placement in adult patients. Note: In general, devices that utilize ECG technique to…
Read the full statement (127 words)
The PICC Tip Positioning Aid is indicated for the positioning of Peripherally Inserted Central Catheters (P1CC) in adult patients. It provides real-time catheter tip location information by using the patient's cardiac electrical activity. The PICC Tip Positioning Aid is indicated for use as an alternative method to chest x-ray or fluoroscopy confirmation of PICC tip placement in adult patients.
Note: In general, devices that utilize ECG technique to observe P-Wave arc limited, but not contraindicated, for patients where cardiac thythms 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 PICC insertion. Use of an additional confirmation method is necessary 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/K152261 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152261: PICC Tip Positioning Aid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152261
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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