510(k) · Cleared

Cleared

Synchron CX3 Delta

K942676510(k) TraditionalCleared Nov 2, 1994149-day reviewClass I21 CFR 862.2170

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Beckman-Diagnostic Systems Group · JJF Analyzer, Chemistry, Micro, For Clinical Use

Cleared on Nov 2, 1994 after a 149-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 22 later devices descend from it.

Decided: Nov 2, 1994
Review: 149 days
Class: Class I
Product code: JJF
Recalls: None
Predicates: 0

22 later devices descend from it, 5 citing it directly.

This deviceK942676 Synchron CX3 DeltaBeckman-Diagnostic Systems Group · 1994
Descendant · cites it directly · 17 of its ownK965240 Synchron LX 20 Clinical Chemistry System, Synchron LX Albumin…Beckman Instruments, Inc. · 1997 · Recalled
Descendant · 2 generations on · 11 of its ownK042291 Unicel DXC 600 and 800 Synchron SystemsBeckman Coulter, Inc. · 2004 · Recalled
Descendant · 3 generations on · 5 of its ownK183688 i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2020
Descendant · 3 generations on · 4 of its ownK183678 i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2020
Descendant · 3 generations on · 4 of its ownK191298 i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2020

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

1997high 5 (2004) · low 0 (1998)2026

Most influential descendants

Showing 5 of 22 · See all

K965240Synchron LX 20 Clinical Chemistry System, Synchron LX Albumin Reagent, Synchron LX…Beckman Instruments, Inc. · 1997 · cites it directly17descendants
K042291Unicel DXC 600 and 800 Synchron SystemsBeckman Coulter, Inc. · 2004 · 2 generations on11descendants
K183688i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2020 · 3 generations on5descendants
K183678i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2020 · 3 generations on4descendants
K191298i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2020 · 3 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K942676	Synchron CX3 Delta	Beckman-Diagnostic Systems Group	1994	—
+1	K965240	Synchron LX 20 Clinical Chemistry System, Synchron LX Albumin Reagent…	Beckman Instruments, Inc.	1997	12
+2	K042291	Unicel DXC 600 and 800 Synchron Systems	Beckman Coulter, Inc.	2004	34
+3	K183688	i-STAT CHEM8+ cartridge with the i-STAT 1 System	Abbott Point of Care, Inc.	2020	—
+3	K183678	i-STAT CHEM8+ cartridge with the i-STAT 1 System	Abbott Point of Care, Inc.	2020	—
+3	K191298	i-STAT CHEM8+ cartridge with the i-STAT 1 System	Abbott Point of Care, Inc.	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	3	0
2001	1	0
2003	1	0
2004	5	0
2006	1	0
2007	2	0
2011	1	0
2020	3	0
2021	1	0
2023	3	0
2026	1	0

FIG. 1 — Lineage of K942676, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 JJF? 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

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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? (22)

See all 22

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K965240	Synchron LX 20 Clinical Chemistry System, Synchron LX Albumin Reagent, Synchron LX…	Beckman Instruments, Inc.	1997	17
K033060	Calibrating Material, Calibrating Standards	Diamond Diagnostics, Inc.	2004	0
K033056	Bun Reagent for Beckman Synchron CX & CX Delta Reagent	Diamond Diagnostics, Inc.	2004	0
K033055	Glucose Reagent for Beckman Synchron CX & CX Delta Systems	Diamond Diagnostics, Inc.	2004	0
K033061	Calibrating Material, Ise Electrolyte Reference	Diamond Diagnostics, Inc.	2003	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, K965240 (Beckman Instruments, Inc., 1997) has gone furthest, with 17 descendants of its own.

How does its category compare?

All JJF devices

JJF Analyzer, Chemistry, Micro, For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJF

FDA has decided no JJF device since 2007.

Median 510(k) review, days · JJF

Too few JJF 510(k)s in any year since 2007 to give a median.

Recalls per year · JJF

2in 2018

2007high 3 (2012) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JJF

2in 2025

2007high 21 (2010) · low 0 (2015)2025

MAUDE reports naming product code JJF, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	2	10
2008	—	0	2
2009	—	0	3
2010	—	0	21
2011	—	0	19
2012	—	3	8
2013	—	0	1
2014	—	0	3
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	2	0
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	1
2023	—	0	1
2024	—	0	0
2025	—	0	2
2026	—	0	—

https://510kreport.com/device/K942676 · printed Nov 6, 2026

Cite this page

510(k) Report. “K942676: Synchron CX3 Delta.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K942676

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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