# K974431: Chemo-Spike II Reconstitution Device

- Pathway: 510(k) (Traditional)
- Applicant: Medi-Dose, Inc.
- Decided: Jan 8, 1998 after 45 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 K941020 (1994). 2 ancestors in all.
13 later devices descend from it; 1 cites it directly.
2 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941020: Drug Reconstitution Filter Device, Gelman Sciences, Inc. (1994) Summary page 1.
- K946190: Drug Dispensing Spike, Gelman Sciences, Inc. (1995) Summary page 2.

## Most influential descendants
- K081361: Chemoclave Cytotoxic Medication Preparation and Delivery System, Model, CH-XXXX (2008), 12 descendants of its own
- K131549: Chemolock, Chemolock Port (2013), 10 descendants of its own
- K141448: Tevadaptor Closed Drug Reconstitution and Transfer System (2015), 9 descendants of its own
- K192866: Chemfort CSTD (2020), 3 descendants of its own
- K201422: Arisure Closed System Drug Transfer Device (CSTD) (2021), 1 descendant of its own

## Indications for use
The Chemo-Spike II Reconstitution Device is indicated for use in the preparation and dispensing of lyophilized chemotherapy drugs in multiple dose vials. The device is used to either add diluent to the vial or to withdraw medication from the vial. These medications and devices should be used by hospital medical personnel properly trained in aseptic procedures. The Chemo-Spike II Reconstitution Device is indicated for use prior to patient administration or physician use. The Dispensing-Spike II Device is indicated for use in the preparation and dispensing of IV medication from multiple dose IV vials. The device is used to either add diluent to the vial or to withdraw medication from the vial. These medications and devices should be used by hospital medical personnel skilled and trained in maintaining aseptic technique. The Dispensing-Spike II is indicated for use prior to patient administration or physician use.

Source page: https://510kreport.com/device/K974431
Methodology: https://510kreport.com/methodology