510(k) · Cleared

Recalled · 2010

Synchon CX Delta Clin Syst (CX4, CX5, CX7 Delta)

K950958510(k) TraditionalCleared May 8, 199582-day reviewClass I21 CFR 862.2160Recalls 4

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

Beckman Instruments, Inc. · JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Cleared on May 8, 1995 after an 82-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 19 later devices descend from it. It has been recalled 4 times.

Decided: May 8, 1995
Review: 82 days
Class: Class I
Product code: JJE
Recalls: 4
Predicates: 0

19 later devices descend from it, 3 citing it directly.

This deviceK950958 Synchon CX Delta Clin Syst (CX4, CX5, CX7 Delta)Beckman Instruments, Inc. · 1995
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 19 descendants. See all descendants

Descendants cleared per year

1997high 3 (1997) · low 0 (1998)2026

Most influential descendants

Showing 5 of 19 · 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)	K950958	Synchon CX Delta Clin Syst (CX4, CX5, CX7 Delta)	Beckman Instruments, Inc.	1995	—
+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
2004	2	0
2006	1	0
2007	3	0
2011	1	0
2020	3	0
2021	1	0
2023	3	0
2026	1	0

FIG. 1 — Lineage of K950958, 1995–2026Source: 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 JJE? 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? (19)

See all 19

3 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
K071280	Synchron CX Delta Clinical Systems, Creatinine Test Systems	Beckman Coulter, Inc.	2007	0
K971505	Synchron Systems Cholesterol (Chol) Reagent	Beckman Instruments, Inc.	1997	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 23, 2010	Not classified	Z-0128-2012	Software design	The recall was initiated because Beckman Coulter has confirmed software limitations which affect only manually-loaded reagent cartridges on the CX4/5/7 CE, CX4/5/7 Delta and CX9 ALX Clinical Systems.
Aug 23, 2010	Not classified	Z-0125-2012	Software design	The recall was initiated because Beckman Coulter has confirmed software limitations which affect only manually-loaded reagent cartridges on the CX4/5/7 CE, CX4/5/7 Delta and CX9 ALX Clinical Systems.
Aug 23, 2010	Not classified	Z-0131-2012	Software design	The recall was initiated because Beckman Coulter has confirmed software limitations which affect only manually-loaded reagent cartridges on the CX4/5/7 CE, CX4/5/7 Delta and CX9 ALX Clinical Systems.
Aug 23, 2010	Not classified	Z-0132-2012	Software design	The recall was initiated because Beckman Coulter has confirmed software limitations which affect only manually-loaded reagent cartridges on the CX4/5/7 CE, CX4/5/7 Delta and CX9 ALX Clinical Systems.

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 JJE devices

JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJE

1in 2019

2007high 3 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJE

224in 2014

2007high 224 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JJE

6in 2025

2007high 32 (2010) · low 0 (2022)2026

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

Adverse event reports per year · JJE

4,400in 2025

2007high 11,606 (2011) · low 1,869 (2017)2025

MAUDE reports naming product code JJE, 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	—	20	2,181
2008	1	—	20	2,159
2009	0	—	14	3,440
2010	0	—	32	3,273
2011	2	—	25	11,606
2012	1	—	16	3,707
2013	1	—	21	2,489
2014	3	224	14	2,841
2015	0	—	15	2,793
2016	0	—	9	2,580
2017	0	—	18	1,869
2018	0	—	17	4,590
2019	1	—	7	3,948
2020	0	—	7	3,986
2021	0	—	6	3,920
2022	0	—	0	3,998
2023	0	—	12	3,783
2024	0	—	6	4,221
2025	0	—	6	4,400
2026	0	—	5	—

https://510kreport.com/device/K950958 · printed Nov 4, 2026

Cite this page

510(k) Report. “K950958: Synchon CX Delta Clin Syst (CX4, CX5, CX7 Delta).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K950958

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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