# K960669: Hydragel IF, 6 IF, 12 IF Penta Kits/Hydragel IF, Double IF, 2 IF, & 4 IF Kits

- Pathway: 510(k) (Traditional)
- Applicant: Morax
- Decided: Jul 12, 1996 after 143 days
- Product code: CFF (Immunoelectrophoretic, Immunoglobulins, (G, A, M))
- Device class: 2
- Regulation: 21 CFR 866.5510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 4 cite it directly.
0 of 8 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
- K130500: Capillarys Immunotyping, Capillarys 2 Instrument, IT/IF Control, Capillarys 2 Flex Piercing Instrument (2013), 2 descendants of its own
- K172195: HYDRASHIFT 2/4 daratumumab, daratumumab Control (2018), 1 descendant of its own
- K161928: Capi 3 Immunotyping, Capillarys 3 Tera, IT/IF Control (2016), 1 descendant of its own
- K250159: Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser (2025), 0 descendants of its own
- K203184: HYDRASHIFT 2/4 isatuximab (2021), 0 descendants of its own

Source page: https://510kreport.com/device/K960669
Methodology: https://510kreport.com/methodology