# K132592: Flexor Radial Hydrophilic Introducer Access Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Oct 9, 2014 after 416 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K954234 (1995). 13 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 16 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122980: Glidesheath Slender Model RM* ES6J10HQS, Glidesheath Slender Model RM* ES6F16HQ, Glidesheath Slender Model RM * RS6J10PQ, Terumo Medical Corporation (2012) Summary page 4.
- K082847: Pinnacle Roii Introducer Sheath, Terumo Medical Corp. (2008) Summary page 4.
- K110051: Radialsource Transradial Access Introducer Kit, Great Batch Medical (2012) Summary page 4.

## Most influential descendants
- K152044: Flexor Radial Hydrophilic Introducer Access Set (2015), 1 descendant of its own
- K171609: Check-Flo Performer Introducer Micropuncture Radial Artery Access Set (2018), 0 descendants of its own

## Recalls of this device
- Feb 1, 2017 · Class II · Z-1387-2017: Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay
- Feb 1, 2017 · Class II · Z-1391-2017: Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay
- Feb 1, 2017 · Class II · Z-1393-2017: Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay
- Feb 1, 2017 · Class II · Z-1389-2017: Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay
- Feb 1, 2017 · Class II · Z-1388-2017: Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay
- Feb 1, 2017 · Class II · Z-1390-2017: Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay i
- Feb 1, 2017 · Class II · Z-1392-2017: Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay

## Indications for use
The Flexor® Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices in radial artery access procedures.

Source page: https://510kreport.com/device/K132592
Methodology: https://510kreport.com/methodology