510(k) · Cleared
ClearedCX (TM) Benzodiazepine (Benz) Reagent for Sychron CX Sys
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Instruments, Inc. · JXM Enzyme Immunoassay, Benzodiazepine
Cleared on Nov 21, 1994 after a 139-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Nov 21, 1994
- Review
- 139 days
- Class
- Class II
- Product code
- JXM
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK944076 CX (TM) Benzodiazepine (Benz) Reagent for Sychron CX SysBeckman Instruments, Inc. · 1994
- Descendant · cites it directly · 2 of its ownK023048 Modification to Synchron Systems Benzodiazepine ReagentBeckman Coulter, Inc. · 2002
- Descendant · 2 generations on · 0 of its ownK051307 Synchron Systems Bebzodiazapine (Ebnz) ReagentBeckman Coulter, Inc. · 2005
- Descendant · 2 generations on · 0 of its ownK043556 Synchron Systems Benzodiazepine (BNZG) ReagentBeckman Coulter, Inc. · 2005
Most influential descendants
Showing 3 of 3 · See all- K023048Modification to Synchron Systems Benzodiazepine ReagentBeckman Coulter, Inc. · 2002 · cites it directly2descendants
- K051307Synchron Systems Bebzodiazapine (Ebnz) ReagentBeckman Coulter, Inc. · 2005 · 2 generations on0descendants
- K043556Synchron Systems Benzodiazepine (BNZG) ReagentBeckman Coulter, Inc. · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944076 | CX (TM) Benzodiazepine (Benz) Reagent for Sychron CX Sys | Beckman Instruments, Inc. | 1994 | — |
| +1 | K023048 | Modification to Synchron Systems Benzodiazepine Reagent | Beckman Coulter, Inc. | 2002 | — |
| +2 | K051307 | Synchron Systems Bebzodiazapine (Ebnz) Reagent | Beckman Coulter, Inc. | 2005 | — |
| +2 | K043556 | Synchron Systems Benzodiazepine (BNZG) Reagent | Beckman Coulter, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 2 | 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 JXM? 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 JXM device
- #1 K243498 Alinity c Benzodiazepines Reagent Kitscore 8.8 · 2 generations · no Class I recall
- #2 Held for the reportin 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? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023048 | Modification to Synchron Systems Benzodiazepine Reagent | 2002 | 2 |
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, K023048 (Beckman Coulter, Inc., 2002) has gone furthest, with 2 descendants of its own.
How does its category compare?
All JXM devicesJXM Enzyme Immunoassay, Benzodiazepine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JXM
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JXM
Too few JXM 510(k)s in any year since 2007 to give a median.
Recalls per year · JXM
79in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JXM
6in 2025
MAUDE reports naming product code JXM, 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 | 3 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 79 | 5 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 2 | — | 0 | 4 |
| 2018 | 1 | — | 0 | 4 |
| 2019 | 1 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 1 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K944076 · printed Nov 4, 2026
Cite this page
510(k) Report. “K944076: CX (TM) Benzodiazepine (Benz) Reagent for Sychron CX Sys.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K944076
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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