510(k) · Cleared
ClearedHydragel IF, 6 IF, 12 IF Penta Kits/Hydragel IF, Double IF, 2 IF, & 4 IF Kits
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Morax · CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Cleared on Jul 12, 1996 after a 143-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 7 later devices descend from it.
- Decided
- Jul 12, 1996
- Review
- 143 days
- Class
- Class II
- Product code
- CFF
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 4 citing it directly.
- This deviceK960669 Hydragel IF, 6 IF, 12 IF Penta Kits/Hydragel IF, Double IF, 2 IF, &…Morax · 1996
- Descendant · cites it directly · 2 of its ownK130500 Capillarys Immunotyping, Capillarys 2 Instrument, IT/IF Control…Sebia · 2013
- Descendant · cites it directly · 1 of its ownK172195 HYDRASHIFT 2/4 daratumumab, daratumumab ControlSebia · 2018
- Descendant · 2 generations on · 1 of its ownK161928 Capi 3 Immunotyping, Capillarys 3 Tera, IT/IF ControlSebia · 2016
- Descendant · cites it directly · 0 of its ownK250159 Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT AnalyserThe Binding Site Group, Ltd. · 2025 · Recalled
- Descendant · cites it directly · 0 of its ownK203184 HYDRASHIFT 2/4 isatuximabSebia · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K130500Capillarys Immunotyping, Capillarys 2 Instrument, IT/IF Control, Capillarys 2 Flex…Sebia · 2013 · cites it directly2descendants
- K172195HYDRASHIFT 2/4 daratumumab, daratumumab ControlSebia · 2018 · cites it directly1descendant
- K161928Capi 3 Immunotyping, Capillarys 3 Tera, IT/IF ControlSebia · 2016 · 2 generations on1descendant
- K250159Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT AnalyserThe Binding Site Group, Ltd. · 2025 · cites it directly0descendants
- K203184HYDRASHIFT 2/4 isatuximabSebia · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960669 | Hydragel IF, 6 IF, 12 IF Penta Kits/Hydragel IF, Double IF, 2 IF, & 4 IF Kits | Morax | 1996 | — |
| +1 | K130500 | Capillarys Immunotyping, Capillarys 2 Instrument, IT/IF Control, Capillarys 2… | Sebia | 2013 | — |
| +1 | K172195 | HYDRASHIFT 2/4 daratumumab, daratumumab Control | Sebia | 2018 | — |
| +2 | K161928 | Capi 3 Immunotyping, Capillarys 3 Tera, IT/IF Control | Sebia | 2016 | — |
| +1 | K250159 | Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser | The Binding Site Group, Ltd. | 2025 | 1 |
| +1 | K203184 | HYDRASHIFT 2/4 isatuximab | Sebia | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CFF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CFF device
- #1 K203184 HYDRASHIFT 2/4 isatuximabscore 2.3 · 1 generation · no Class I recall
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (7)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130500 | Capillarys Immunotyping, Capillarys 2 Instrument, IT/IF Control, Capillarys 2 Flex… | 2013 | 2 |
| K172195 | HYDRASHIFT 2/4 daratumumab, daratumumab Control | 2018 | 1 |
| K250159 | Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser | 2025 | 0 |
| K203184 | HYDRASHIFT 2/4 isatuximab | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K130500 (Sebia, 2013) has gone furthest, with 2 descendants of its own.
How does its category compare?
All CFF devicesCFF Immunoelectrophoretic, Immunoglobulins, (G, A, M): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CFF
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · CFF
Too few CFF 510(k)s in any year since 2007 to give a median.
Recalls per year · CFF
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CFF
1in 2021
MAUDE reports naming product code CFF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 1 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 1 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K960669 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960669: Hydragel IF, 6 IF, 12 IF Penta Kits/Hydragel IF, Double IF, 2 IF, & 4 IF Kits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960669
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026