# K983794: Chemo Mini Spike Plus

- Pathway: 510(k) (Traditional)
- Applicant: B. Braun of America, Inc.
- Decided: Mar 23, 1999 after 147 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: 1 generation back to K925401 (1993). 1 ancestor in all.
13 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925401: IV Fluid Transfer Pin, B. Braun of America, Inc. (1993) Summary page 1.

## Most influential descendants
- K052790: Smartsite Vented Vial  Access Device, Model TBD (2005), 5 descendants of its own
- K062482: Vented Vial Adapter Transfer Device (2006), 4 descendants of its own
- K160503: Vented Vial Adapter Transfer Device - 13mm (2016), 2 descendants of its own
- K201469: Mini Spike Plus 6/8R (2020), 1 descendant of its own
- K151963: SmartSite Vented Vial Access Device (2015), 1 descendant of its own

## Indications for use
An IV additive dispensing pin for aspiration from multidose containers or injection into IV systems (IV bag).

Source page: https://510kreport.com/device/K983794
Methodology: https://510kreport.com/methodology