# K261529: Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)

- Pathway: 510(k) (Traditional)
- Applicant: Hartman Medical Group, LLC
- Decided: Jul 6, 2026 after 59 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: 10 generations back to K954234 (1995). 19 ancestors in all.
No later device cites it as a predicate yet.
1 of 20 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232260: Thinline Sheath Introducer, Inneuroco, Inc. (2023) Summary page 6.

## Indications for use
The Introducer Set is intended to facilitate the introduction of guidewires, catheters, and other accessory medical devices through the skin into a vessel while maintaining hemostasis.

Source page: https://510kreport.com/device/K261529
Methodology: https://510kreport.com/methodology