510(k) · Cleared
ClearedIcs Apolipoprotein a-1 Reagent Test Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Instruments, Inc. · MSJ Apolipoproteins
Cleared on Jul 18, 1986 after a 51-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.
- Decided
- Jul 18, 1986
- Review
- 51 days
- Class
- Class I
- Product code
- MSJ
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK862019 Ics Apolipoprotein a-1 Reagent Test KitBeckman Instruments, Inc. · 1986
- Descendant · cites it directly · 0 of its ownK964010 Immage Immunochemistry System Apolipoprotein a-1 Reagent (Apa)/…Beckman Instruments, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK962294 Immage Immunochemistry SystemBeckman Instruments, Inc. · 1996 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K862019 | Ics Apolipoprotein a-1 Reagent Test Kit | Beckman Instruments, Inc. | 1986 | — |
| +1 | K964010 | Immage Immunochemistry System Apolipoprotein a-1 Reagent (Apa)/ Immage… | Beckman Instruments, Inc. | 1997 | — |
| +1 | K962294 | Immage Immunochemistry System | Beckman Instruments, Inc. | 1996 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 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 MSJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K964010 (Beckman Instruments, Inc., 1997) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MSJ devicesMSJ Apolipoproteins: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MSJ
2in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · MSJ
Too few MSJ 510(k)s in any year since 2007 to give a median.
Recalls per year · MSJ
No recall names MSJ since 2007.
Adverse event reports per year · MSJ
No MAUDE report names MSJ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K862019 · printed Nov 6, 2026
Cite this page
510(k) Report. “K862019: Ics Apolipoprotein a-1 Reagent Test Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K862019
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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