510(k) · Cleared
ClearedNeonav ECG Tip Location System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Navi Medical Technologies · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Apr 17, 2026 as substantially equivalent to K241910 (Navi Medical Technologies, 2025) after a 28-day review. Its family tree reaches back 13 generations to 2000.
- Decided
- Apr 17, 2026
- Review
- 28 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K001901 (2000). 36 ancestors in all, the oldest K823434 (1982). No later device cites it as a predicate yet.
- Root · 13 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 9 generations between
- 3 generations backK113808 The Sherlock 3CG Tip Confirmation System (TCS)C.R. Bard, Inc. · 2012
- 2 generations backK141634 Nautilus DeltaRomedex International Srl · 2015
- 1 generation backK241910 Neonav ECG Tip Location SystemNavi Medical Technologies · 2025
- This deviceK260929 Neonav ECG Tip Location SystemNavi Medical Technologies · 2026
Show all 13 generations
- Root · 13 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 12 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 11 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 10 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 9 generations backK060341 Sherlock Tip Location System (TLS)C.R. Bard, Inc. · 2006
- 8 generations backK063240 Sherlock TLS Stylet, Sherlock TLS DetectorC.R. Bard, Inc. · 2006 · Recalled
- 7 generations backK081625 Flowpicc StyletVasonova, Inc. · 2008
- 6 generations backK091324 Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning…C.R. Bard, Inc. · 2009 · Recalled
- 5 generations backK093775 Evguide Tip Location SystemRomedex International Srl · 2010
- 4 generations backK112744 Sapiens Tip Confirmation SystemC.R. Bard, Inc. · 2011
- 3 generations backK113808 The Sherlock 3CG Tip Confirmation System (TCS)C.R. Bard, Inc. · 2012
- 2 generations backK141634 Nautilus DeltaRomedex International Srl · 2015
- 1 generation backK241910 Neonav ECG Tip Location SystemNavi Medical Technologies · 2025
- This deviceK260929 Neonav ECG Tip Location SystemNavi Medical Technologies · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −12 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −11 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −10 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −9 | K060341 | Sherlock Tip Location System (TLS) | C.R. Bard, Inc. | 2006 | — |
| −8 | K063240 | Sherlock TLS Stylet, Sherlock TLS Detector | C.R. Bard, Inc. | 2006 | 18 |
| −7 | K081625 | Flowpicc Stylet | Vasonova, Inc. | 2008 | — |
| −6 | K091324 | Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System Stylet | C.R. Bard, Inc. | 2009 | 11 |
| −5 | K093775 | Evguide Tip Location System | Romedex International Srl | 2010 | — |
| −4 | K112744 | Sapiens Tip Confirmation System | C.R. Bard, Inc. | 2011 | — |
| −3 | K113808 | The Sherlock 3CG Tip Confirmation System (TCS) | C.R. Bard, Inc. | 2012 | — |
| −2 | K141634 | Nautilus Delta | Romedex International Srl | 2015 | — |
| −1 | K241910 | Neonav ECG Tip Location System | Navi Medical Technologies | 2025 | — |
| 0 (this device) | K260929 | Neonav ECG Tip Location System | Navi Medical Technologies | 2026 | — |
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 |
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 |
|---|---|---|---|
| * | K241910 | Neonav ECG Tip Location SystemSummary page 5….5970 Product Code(s) LJS | Legally Marketed Predicate Devices Predicate # 21 CFR 807.92(a)(3) Product Code Predicate Trade Name (Primary Predicate is listed first) K241910 LJS 21 CFR 807.92(a)(4) Neonav ECG Tip Location System Device Description Summary The Neonav ECG Tip Location System (Neonav)… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 7 of the 36 ancestors have a recall of any class.
- 1 other device also cites its predicate K241910.
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. 2026, 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?
Neonav is indicated for navigation and positioning of central venous access devices (CVADs) of at least 1 Fr in size. Neonav provides real-time catheter tip location information by using the patient's cardiac electrical activity. Neonav is indicated for use as an alternative method to chest X-ray and fluoroscopy for all central venous access device tip placement confirmation. In adult patients and in adolescents (greater than 12 through 21 years of age)…
Read the full statement (246 words)
Neonav is indicated for navigation and positioning of central venous access devices (CVADs) of at least 1 Fr in size. Neonav provides real-time catheter tip location information by using the patient's cardiac electrical activity. Neonav is indicated for use as an alternative method to chest X-ray and fluoroscopy for all central venous access device tip placement confirmation.
In adult patients and in adolescents (greater than 12 through 21 years of age), Neonav can be used with CVADs such as peripherally inserted central catheters (PICCs), centrally inserted central catheters (CICCs), implantable ports, and hemodialysis catheters; in children (greater than 2 to 12 years of age), Neonav can be used with PICCs and with CICCs; in infants (greater than 1 month to 2 years of age), Neonav can be used with PICCs and CICCs; and in neonates (from birth to 1 month of age), Neonav can be used with PICCs, CICCs, and umbilical venous catheters (UVCs). In each specific age group, the CVAD type and size must be chosen and the CVAD must be used according to the CVAD's indications and instructions for use.
Limiting but not contraindicated situations for use of the Neonav 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 central venous access device 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/K260929 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260929: Neonav ECG 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/K260929
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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