# K113808: The Sherlock 3CG Tip Confirmation System (TCS)

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Mar 19, 2012 after 87 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: 10 generations back to K001901 (2000). 33 ancestors in all.
6 later devices descend from it; 2 cite 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)
- K112744: Sapiens Tip Confirmation System, C.R. Bard, Inc. (2011) Summary page 1.
- K091324: Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System Stylet, C.R. Bard, Inc. (2009) Summary page 1.

## Most influential descendants
- 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
- K260929: Neonav ECG Tip Location System (2026), 0 descendants of its own

## Indications for use
The Sherlock 3 CG TM Tip Confirmation System (TCS) is indicated for guidance and positioning of Peripherally Inserted Central Catheters (PICCs). The Sherlock 3CG TCS provides real-time PICC tip location information by using passive magnet tracking and the patient's cardiac electrical activity (ECG). When relying on the patient's ECG signal, the Sherlock 3CG TOS 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 catheter insertion, the use of an additional method is required to confirm P1CC tip location:

Source page: https://510kreport.com/device/K113808
Methodology: https://510kreport.com/methodology