# K060341: Sherlock Tip Location System (TLS)

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Apr 14, 2006 after 63 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K001901 (2000). 9 ancestors in all.
43 later devices descend from it; 1 cites it directly.
6 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023374: Groshong NXT Dual Lumen Picc Catheters, C.R. Bard, Inc. (2002) Summary page 1.
- K034019: Poly Per-Q-Cath Picc Catheters, C.R. Bard, Inc. (2004) Summary page 1.
- K935380: Vascular Access Catheter Accessories, Bard Access Systems, Inc. (1995) Summary page 2.
- K000997: Zortran Detector, Lucent Medical Systems (2000) Summary page 2.

## Most influential descendants
- K063240: Sherlock TLS Stylet, Sherlock TLS Detector (2006), 42 descendants of its own
- K081625: Flowpicc Stylet (2008), 40 descendants of its own
- K081626: Flowpicc Console (2008), 39 descendants of its own
- K091324: Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System Stylet (2009), 38 descendants of its own
- K093775: Evguide Tip Location System (2010), 34 descendants of its own

## Indications for use
Catheter stylets provide internal reinforcement to aid in catheter placement. The Sherlock TLS Stylet contains passive magnets that generate a magnetic field. This field can be detected by the Sherlock TLS Detector to provide the placer rapid feedback on catheter tip location.

Source page: https://510kreport.com/device/K060341
Methodology: https://510kreport.com/methodology