# K112744: Sapiens Tip Confirmation System

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Oct 20, 2011 after 29 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: 9 generations back to K001901 (2000). 32 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093775: Evguide Tip Location System, Romedex International Srl (2010) Summary page 1.

## Most influential descendants
- K113808: The Sherlock 3CG Tip Confirmation System (TCS) (2012), 6 descendants of its own
- K141634: Nautilus Delta (2015), 4 descendants of its own
- K241910: Neonav ECG Tip Location System (2025), 2 descendants of its own
- K140345: The Sherlock 3CG Tip Confirmation System (TCS) (2014), 2 descendants of its own
- K180560: Sherlock 3CG+ T ip Confirmation System (2018), 1 descendant of its own

## Indications for use
The Sapiens t Tip Confirmation System (TICS) is indicated for guidance and positioning of Peripherally Inserted Central Catheters (PIOCs). The Sapiens* TCS provides real-time P1CC tip location information by using the patient's cardiac electrical activity. Sapiens* TCS is indicated for use as an alternative method to chest X-ray and fluoroscopy for P1CC 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. In such patients, who are easily identifiable prior to P1CC insertion, the use of an additional method is required to confirm catheter tip location.

Source page: https://510kreport.com/device/K112744
Methodology: https://510kreport.com/methodology