# K201469: Mini Spike Plus 6/8R

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Dec 9, 2020 after 189 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K925401 (1993). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983794: Chemo Mini Spike Plus, B. Braun of America, Inc. (1999) Summary page 4.

## Most influential descendants
- K260301: Vial Adapter (2026), 0 descendants of its own

## Indications for use
An 1V additive dispensing pin for aspiration from single-dose containers with a 20 mm vial closure diameter and a 22mm vial body diameter (6R/8R).

Source page: https://510kreport.com/device/K201469
Methodology: https://510kreport.com/methodology