# K000737: Coaxial Dilator Set

- Pathway: 510(k) (Traditional)
- Applicant: Xentek Medical, Inc.
- Decided: Aug 1, 2000 after 147 days
- Product code: DRE (Dilator, Vessel, For Percutaneous Catheterization)
- Device class: 2
- Regulation: 21 CFR 870.1310
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K062627: Innerchange Micro-Introducer Catheter, Models 7900 Through 7905 (2007), 2 descendants of its own
- K172487: Coaxial Dilator Set (Micro-Introducer) (2017), 1 descendant of its own
- K073585: Innerchange Micro-Introducer Catheter, Models 7900, 7901, 7902, 7903, 7904 and 7905 (2008), 1 descendant of its own
- K071330: Galtstick Introducer System (2007), 1 descendant of its own
- K192195: Sterile Dilator (2019), 0 descendants of its own

## Recalls of this device
- Jun 26, 2026 · Class II · Z-2917-2026: Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.
- Mar 27, 2025 · Class II · Z-1732-2025: Due to a potential open seal in the sterile barrier packaging .
- May 2, 2018 · Class II · Z-2561-2018: The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate th
- May 2, 2018 · Class II · Z-2564-2018: The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate th
- Feb 8, 2010 · Not classified · Z-1592-2010: Potential problem with pouch seal thus affecting sterile product.

Source page: https://510kreport.com/device/K000737
Methodology: https://510kreport.com/methodology