# K091324: Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System Stylet

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Aug 7, 2009 after 94 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: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K001901 (2000). 28 ancestors in all.
38 later devices descend from it; 4 cite it directly.
6 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061240: Sherlock Tip Location System (TLS) Detector and Accessories, Lucent Medical Systems (2006) Summary page 1.
- K063240: Sherlock TLS Stylet, Sherlock TLS Detector, C.R. Bard, Inc. (2006) Summary page 1.
- K081626: Flowpicc Console, Vasonova, Inc. (2008) Summary page 1.
- K081625: Flowpicc Stylet, Vasonova, Inc. (2008) Summary page 1.

## Most influential descendants
- K093775: Evguide Tip Location System (2010), 34 descendants of its own
- 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

## Recalls of this device
- May 21, 2026 · Class II · Z-2658-2026: Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
- Feb 26, 2020 · Class II · Z-2077-2020: The kits contain surgical gowns which were subject to a recall by the supplier.
- Feb 26, 2020 · Class II · Z-2079-2020: The kits contain surgical gowns which were subject to a recall by the supplier.
- Feb 26, 2020 · Class II · Z-2082-2020: The kits contain surgical gowns which were subject to a recall by the supplier.
- Feb 26, 2020 · Class II · Z-2075-2020: The kits contain surgical gowns which were subject to a recall by the supplier.
- Feb 26, 2020 · Class II · Z-2076-2020: The kits contain surgical gowns which were subject to a recall by the supplier.
- Feb 26, 2020 · Class II · Z-2078-2020: The kits contain surgical gowns which were subject to a recall by the supplier.
- May 27, 2015 · Class III · Z-2049-2015: Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling.
- May 27, 2015 · Class III · Z-2048-2015: Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling.
- May 27, 2015 · Class III · Z-2047-2015: Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling.
- May 27, 2015 · Class III · Z-2050-2015: Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling.

## Indications for use
Catheter stylets provide internal reinforcement to aid in catheter placement. When used with the Sherlock 3CG TM Tip Positioning System (TPS), the Sherlock 3CG TM TPS Stylet also provides the placer rapid feedback on catheter tip location and orientation through the use of passive magnets and cardiac electrical signal detection. The Sherlock 3CG TM Tip Positioning System (TPS) is indicated for central venous catheter guidance and positioning during catheter placement. The Sherlock 3CG TM TPS provides real time catheter tip location information through the use of passive magnet and cardiac electrical signal detection.

Source page: https://510kreport.com/device/K091324
Methodology: https://510kreport.com/methodology