# K142445: Pinpoint GT Safety Introducer Needle

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Apr 13, 2015 after 223 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K801941 (1980). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050023: Secureloc; Advancintroducer, Specialized Health Products, Inc. (2005) Summary page 4.

## Most influential descendants
- K162769: Pinpoint GT Introducer Needle (2016), 0 descendants of its own

## Indications for use
The Pinpoint™ GT Safety Introducer Needle is intended for patients requiring percutaneous access to place a guidewire for subsequent placement of catheters or other medical procedures requiring introducer needle access. The Pinpoint™ GT Safety Introducer Needle may be used in any appropriate patient population.

Source page: https://510kreport.com/device/K142445
Methodology: https://510kreport.com/methodology