# K921860: Modification to IV Spike

- Pathway: 510(k) (Traditional)
- Applicant: Mcgaw, Inc.
- Decided: Jul 30, 1992 after 141 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
21 later devices descend from it; 3 cite it directly.
6 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K972678: Millennium CRT Infusion Pump and Millennium CRT Infusion Pump Administration Sets (1997), 16 descendants of its own
- K062700: Infusomat Space Volumetric Infusion Pump System (2006), 15 descendants of its own
- K140838: IV Administration Set with Hand Pump (2014), 6 descendants of its own
- K083689: Infusomat Space Volumetric Infusion Pump System (2009), 4 descendants of its own
- K170595: IV Administration Sets (2017), 3 descendants of its own

## Recalls of this device
- Aug 5, 2013 · Class II · Z-2166-2013: Reports were received of an incorrectly assembled Outlook Safety Infusion System Burette Set (Product Code 375038), and the investigation determined that one of the ULTRASITE injection sites and corre
- Jun 30, 2008 · Not classified · Z-2408-2008: incorrect burette was packaged with the product
- Jun 30, 2008 · Not classified · Z-2409-2008: incorrect burette was packaged with the product
- Jun 30, 2008 · Not classified · Z-2414-2008: incorrect burette was packaged with the product
- Jun 30, 2008 · Not classified · Z-2407-2008: incorrect burette was packaged with the product
- Jun 30, 2008 · Not classified · Z-2411-2008: incorrect burette was packaged with the product

Source page: https://510kreport.com/device/K921860
Methodology: https://510kreport.com/methodology