# K093775: Evguide Tip Location System

- Pathway: 510(k) (Traditional)
- Applicant: Romedex International Srl
- Decided: Jul 15, 2010 after 219 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: 8 generations back to K001901 (2000). 31 ancestors in all.
34 later devices descend from it; 5 cite it directly.
6 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091324: Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System Stylet, C.R. Bard, Inc. (2009) Summary page 1.
- K032613: Temporary Transvenous Pacemaker Placement Assist Device, Peter M. Rothenberg, M.D. (2003) Summary page 1.
- K843263: Arrow-Johans Ecg Adaptor, Arrow Intl., Inc. (1984) Summary page 1.

## Cited in the summary but kept off the family tree
- K973371: Certodyn Raecg Universal Adapter, B.Braun Medical, Inc. (1997). Our OCR of the scanned summary read 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, “Conduction Anesthesia Kit”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K140799: Celerity Sysyem (2014), 13 descendants of its own
- K103255: Vascular Positioning System TM (VPS TM System) Stylet (2011), 10 descendants of its own
- K142889: Celerity PICC Tip Confirmation System (2015), 8 descendants of its own
- K112744: Sapiens Tip Confirmation System (2011), 7 descendants of its own
- K113808: The Sherlock 3CG Tip Confirmation System (TCS) (2012), 6 descendants of its own

## Indications for use
The Sapiens™ Tip Location System (TLS) is indicated for guidance and positioning of central venous catheters such as PICCs, CVCs, implantable ports, and hemodialysis catheters. The Sapiens™ TLS provides real-time catheter tip location information by using the patient’s cardiac electrical activity. Sapiens™ TLS is indicated for use as an alternative method to chest X-ray and fluoroscopy for central venous catheter tip placement confirmation in adult patients. Limiting but not contraindicated situations for this technique 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, and in central venous catheterization procedures performed through femoral or saphaneous vein access which change the presentation of the P wave. 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/K093775
Methodology: https://510kreport.com/methodology