510(k) · Cleared
ClearedNautilus Delta
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Romedex International Srl · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Jan 27, 2015 as substantially equivalent to K113808 (C.R. Bard, Inc., 2012) after a 223-day review. Its family tree reaches back 11 generations to 2000. 4 later devices descend from it.
- Decided
- Jan 27, 2015
- Review
- 223 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K001901 (2000). 34 ancestors in all, the oldest K823434 (1982). 4 later devices descend from it, 2 citing it directly.
- 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 backK112744 Sapiens Tip Confirmation SystemC.R. Bard, Inc. · 2011
- 1 generation backK113808 The Sherlock 3CG Tip Confirmation System (TCS)C.R. Bard, Inc. · 2012
- This deviceK141634 Nautilus DeltaRomedex International Srl · 2015
- Descendant · cites it directly · 2 of its ownK241910 Neonav ECG Tip Location SystemNavi Medical Technologies · 2025
- Descendant · cites it directly · 1 of its ownK180560 Sherlock 3CG+ T ip Confirmation SystemC.R. Bard, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK260929 Neonav ECG Tip Location SystemNavi Medical Technologies · 2026
- Descendant · 2 generations on · 0 of its ownK252792 PM2™ System with ECGuide™ ConnectorPiccolo Medical, Inc. · 2025
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 backK112744 Sapiens Tip Confirmation SystemC.R. Bard, Inc. · 2011
- 1 generation backK113808 The Sherlock 3CG Tip Confirmation System (TCS)C.R. Bard, Inc. · 2012
- This deviceK141634 Nautilus DeltaRomedex International Srl · 2015
Most influential descendants
Showing 4 of 4 · See all- K241910Neonav ECG Tip Location SystemNavi Medical Technologies · 2025 · cites it directly2descendants
- K180560Sherlock 3CG+ T ip Confirmation SystemC.R. Bard, Inc. · 2018 · cites it directly1descendant
- K260929Neonav ECG Tip Location SystemNavi Medical Technologies · 2026 · 2 generations on0descendants
- K252792PM2™ System with ECGuide™ ConnectorPiccolo Medical, Inc. · 2025 · 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 | K112744 | Sapiens Tip Confirmation System | C.R. Bard, Inc. | 2011 | — |
| −1 | K113808 | The Sherlock 3CG Tip Confirmation System (TCS) | C.R. Bard, Inc. | 2012 | — |
| 0 (this device) | K141634 | Nautilus Delta | Romedex International Srl | 2015 | — |
| +1 | K241910 | Neonav ECG Tip Location System | Navi Medical Technologies | 2025 | — |
| +1 | K180560 | Sherlock 3CG+ T ip Confirmation System | C.R. Bard, Inc. | 2018 | — |
| +2 | K260929 | Neonav ECG Tip Location System | Navi Medical Technologies | 2026 | — |
| +2 | K252792 | PM2™ System with ECGuide™ Connector | Piccolo Medical, Inc. | 2025 | — |
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 |
|---|---|---|
| 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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K973371 | FDA’s K973371 is Certodyn Raecg Universal Adapter Our reading of the summary gave K973371, FDA’s number for Certodyn Raecg Universal Adapter (B.Braun Medical, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Epidural Catheter Connector”. Kept off the family tree. Summary page 4…Implanted, Long-Term Intravascular Catheters Classification Panel: General Hospital Predicate devices: Epidural Catheter Connector (K973371) Sherlock 3CG Tip Confirmation System (K113808) Device Description: The Nautilus DeltaTM system c… | 1997 |
| * | K113808 | The Sherlock 3CG Tip Confirmation System (TCS)Summary page 4…assification Panel: General Hospital Predicate devices: Epidural Catheter Connector (K973371) Sherlock 3CG Tip Confirmation System (K113808) Device Description: The Nautilus DeltaTM system consists of the following elements: single use s… | 2012 |
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? (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 15 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- 7 of the 34 ancestors have a recall of any class.
- Of its descendants, K241910 (Navi Medical Technologies, 2025) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K113808.
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?
Nautilus Delta is indicated for navigation and positioning of central venous access devices (CVADs) of at least 3 Fr in size. Nautilus Delta provides real-time catheter tip location information by using the patient’s cardiac electrical activity and is indicated for use as an alternative method to chest X-ray and fluoroscopy for CVAD tip placement confirmation. In adult patients and in adolescents (greater than 12 through 21 years of age), Nautilus Delta…
Read the full statement (233 words)
Nautilus Delta is indicated for navigation and positioning of central venous access devices (CVADs) of at least 3 Fr in size. Nautilus Delta provides real-time catheter tip location information by using the patient’s cardiac electrical activity and is indicated for use as an alternative method to chest X-ray and fluoroscopy for CVAD tip placement confirmation.
In adult patients and in adolescents (greater than 12 through 21 years of age), Nautilus Delta can be used with CVADs such as peripherally inserted central catheters (PICCs), central venous catheters (CVCs), implantable ports, and hemodialysis catheters; in children (greater than 2 to 12 years of age), Nautilus Delta can be used with PICCs and with centrally inserted central catheters (CICCs); in infants (greater than 1 month to 2 years of age) and in neonates (from birth to 1 month of age), Nautilus Delta can be used with CICCs. 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 this method 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 catheter 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/K141634 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141634: Nautilus Delta.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141634
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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