# K141634: Nautilus Delta

- Pathway: 510(k) (Abbreviated)
- Applicant: Romedex International Srl
- Decided: Jan 27, 2015 after 223 days
- Product code: LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5970
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K001901 (2000). 34 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113808: The Sherlock 3CG Tip Confirmation System (TCS), C.R. Bard, Inc. (2012) Summary page 4.

## Cited in the summary but kept off the family tree
- K973371: Certodyn Raecg Universal Adapter, B.Braun Medical, Inc. (1997). 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.

## Most influential descendants
- K241910: Neonav ECG Tip Location System (2025), 2 descendants of its own
- K180560: Sherlock 3CG+ T ip Confirmation System (2018), 1 descendant of its own
- K260929: Neonav ECG Tip Location System (2026), 0 descendants of its own
- K252792: PM2™ System with ECGuide™ Connector (2025), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K141634
Methodology: https://510kreport.com/methodology