510(k) · Cleared

Recalled · 2010

Synchron CX4/CX5 Clinical Chemistry Analyzer Reage

K883181510(k) TraditionalCleared Sep 19, 198854-day reviewClass I21 CFR 862.1030Recalls 2

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

Beckman Instruments, Inc. · CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt

Cleared on Sep 19, 1988 after a 54-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 20 later devices descend from it. It has been recalled 2 times.

Decided: Sep 19, 1988
Review: 54 days
Class: Class I
Product code: CKA
Recalls: 2
Predicates: 0

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

This deviceK883181 Synchron CX4/CX5 Clinical Chemistry Analyzer ReageBeckman Instruments, Inc. · 1988
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 20 descendants. See all descendants

Descendants cleared per year

1997high 3 (1997) · low 0 (1998)2026

Most influential descendants

Showing 5 of 20 · 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)	K883181	Synchron CX4/CX5 Clinical Chemistry Analyzer Reage	Beckman Instruments, Inc.	1988	—
+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	3	0
2006	1	0
2007	2	0
2011	1	0
2014	1	0
2020	3	0
2021	1	0
2023	3	0
2026	1	0

FIG. 1 — Lineage of K883181, 1988–2026Source: 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 CKA? 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? (20)

See all 20

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
K131189	Unicel DXC Synchron Systems Glucose Reagent (Gluh)	Beckman Coulter, Inc.	2014	0
K041643	Synchron Systems Phosphorus (PHS) Reagent	Beckman Coulter, Inc.	2004	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 10, 2010	Not classified	Z-1619-2011	Other	The recall was initiated because Cartridge Glucose (GLU) on UniCel DxC and Synchron LX instruments may give falsely high results for moderately hemolysed samples. The Impact: (1) Neonatal samples drawn by lancets are more likely to be…
Aug 26, 2009	Not classified	Z-1229-2012	Nonconforming Material/Component	A recall was initiated because Beckman has confirmed that the standardization of the Immuno Protein Calibrator Set has been re-established to IFCC Reference Preparation for Plasma Proteins, BCR-470 beginning with lot number M901330.

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 CKA devices

CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CKA

1in 2013

2007high 1 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CKA

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

Recalls per year · CKA

1in 2016

2007high 8 (2007) · low 0 (2008)2026

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

Adverse event reports per year · CKA

8in 2025

2007high 39 (2011) · low 0 (2007)2025

MAUDE reports naming product code CKA, 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	—	8	0
2008	0	—	0	0
2009	0	—	0	0
2010	0	—	1	8
2011	0	—	0	39
2012	1	—	0	8
2013	1	—	0	0
2014	0	—	0	0
2015	0	—	0	0
2016	0	—	1	0
2017	0	—	0	2
2018	0	—	0	1
2019	0	—	0	0
2020	0	—	0	3
2021	0	—	0	2
2022	0	—	0	2
2023	0	—	0	4
2024	0	—	0	10
2025	0	—	0	8
2026	0	—	0	—

https://510kreport.com/device/K883181 · printed Nov 6, 2026

Cite this page

510(k) Report. “K883181: Synchron CX4/CX5 Clinical Chemistry Analyzer Reage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K883181

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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