# K063240: Sherlock TLS Stylet, Sherlock TLS Detector

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Nov 21, 2006 after 26 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: 18 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K001901 (2000). 11 ancestors in all.
42 later devices descend from it; 3 cite it directly.
6 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060341: Sherlock Tip Location System (TLS), C.R. Bard, Inc. (2006) Summary page 1.
- K061240: Sherlock Tip Location System (TLS) Detector and Accessories, Lucent Medical Systems (2006) Summary page 1.

## Most influential descendants
- 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
- K140799: Celerity Sysyem (2014), 13 descendants of its own

## Recalls of this device
- Apr 7, 2021 · Class II · Z-1661-2021: Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connect
- Apr 7, 2021 · Class II · Z-1653-2021: Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connect
- Apr 7, 2021 · Class II · Z-1656-2021: Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connect
- Apr 7, 2021 · Class II · Z-1668-2021: Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connect
- Apr 7, 2021 · Class II · Z-1662-2021: Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connect
- Apr 7, 2021 · Class II · Z-1659-2021: Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connect
- Apr 7, 2021 · Class II · Z-1664-2021: Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connect
- Apr 7, 2021 · Class II · Z-1657-2021: Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connect
- Apr 7, 2021 · Class II · Z-1663-2021: Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connect
- Apr 7, 2021 · Class II · Z-1660-2021: Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connect
- Apr 7, 2021 · Class II · Z-1654-2021: Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connect
- Apr 7, 2021 · Class II · Z-1665-2021: Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connect
- Apr 7, 2021 · Class II · Z-1652-2021: Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connect
- Apr 7, 2021 · Class II · Z-1669-2021: Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connect
- Apr 7, 2021 · Class II · Z-1667-2021: Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connect
- Apr 7, 2021 · Class II · Z-1655-2021: Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connect
- Apr 7, 2021 · Class II · Z-1666-2021: Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connect
- Apr 7, 2021 · Class II · Z-1658-2021: Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connect

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

Source page: https://510kreport.com/device/K063240
Methodology: https://510kreport.com/methodology