510(k) Report

510(k) · Cleared

Cleared

Synchron CX3

K864236510(k) TraditionalCleared Dec 31, 198664-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 Instruments, Inc. · JJF Analyzer, Chemistry, Micro, For Clinical Use

Cleared on Dec 31, 1986 after a 64-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.

Decided
Dec 31, 1986
Review
64 days
Class
Class I
Product code
JJF
Recalls
None
Predicates
0

4 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2004: 3 descendants cleared1990200020102020
  1. This deviceK864236 Synchron CX3Beckman Instruments, Inc. · 1986
  2. Descendant · cites it directly · 0 of its ownK033060 Calibrating Material, Calibrating StandardsDiamond Diagnostics, Inc. · 2004
  3. Descendant · cites it directly · 0 of its ownK033056 Bun Reagent for Beckman Synchron CX & CX Delta ReagentDiamond Diagnostics, Inc. · 2004
  4. Descendant · cites it directly · 0 of its ownK033055 Glucose Reagent for Beckman Synchron CX & CX Delta SystemsDiamond Diagnostics, Inc. · 2004
  5. Descendant · cites it directly · 0 of its ownK033061 Calibrating Material, Ise Electrolyte ReferenceDiamond Diagnostics, Inc. · 2003

Most influential descendants

Showing 4 of 4 · See all
  • K033060Calibrating Material, Calibrating StandardsDiamond Diagnostics, Inc. · 2004 · cites it directly0descendants
  • K033056Bun Reagent for Beckman Synchron CX & CX Delta ReagentDiamond Diagnostics, Inc. · 2004 · cites it directly0descendants
  • K033055Glucose Reagent for Beckman Synchron CX & CX Delta SystemsDiamond Diagnostics, Inc. · 2004 · cites it directly0descendants
  • K033061Calibrating Material, Ise Electrolyte ReferenceDiamond Diagnostics, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K864236Synchron CX3Beckman Instruments, Inc.1986—
+1K033060Calibrating Material, Calibrating StandardsDiamond Diagnostics, Inc.2004—
+1K033056Bun Reagent for Beckman Synchron CX & CX Delta ReagentDiamond Diagnostics, Inc.2004—
+1K033055Glucose Reagent for Beckman Synchron CX & CX Delta SystemsDiamond Diagnostics, Inc.2004—
+1K033061Calibrating Material, Ise Electrolyte ReferenceDiamond Diagnostics, Inc.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200430
FIG. 1 — Lineage of K864236, 1986–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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? (4)

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

NumberDeviceApplicantDecidedDescendants
K033060Calibrating Material, Calibrating StandardsDiamond Diagnostics, Inc.20040
K033056Bun Reagent for Beckman Synchron CX & CX Delta ReagentDiamond Diagnostics, Inc.20040
K033055Glucose Reagent for Beckman Synchron CX & CX Delta SystemsDiamond Diagnostics, Inc.20040
K033061Calibrating Material, Ise Electrolyte ReferenceDiamond Diagnostics, Inc.20030

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, K033060 (Diamond Diagnostics, Inc., 2004) has gone furthest, with 0 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

2007: 22012: 32018: 2
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

2007: 102008: 22009: 32010: 212011: 192012: 82013: 12014: 32022: 12023: 12025: 2
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—210
20080—02
20090—03
20100—021
20110—019
20120—38
20130—01
20140—03
20150—00
20160—00
20170—00
20180—20
20190—00
20200—00
20210—00
20220—01
20230—01
20240—00
20250—02
20260—0—

More from Beckman Instruments, Inc.

281 FDA decisions under this applicant name. See the company

  • K973448Access Toxoplasma Igm Reagents on the Access Immunoassay Analyzer, Models 34460, 34465, 34469Beckman Instruments, Inc. · 1998
  • K982250Access Free T4 Reagents on the Access Immunoassay AnalyzerBeckman Instruments, Inc. · 19984 recalls
  • K981403Immage Immunochemistry System Valproic Acid (Vpa) ReagentBeckman Instruments, Inc. · 1998
  • K981354Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211Beckman Instruments, Inc. · 19981 recall
  • K980173Access Total BHCG Reagents on the Access Immunoassay Analyzer; 33500, 33505Beckman Instruments, Inc. · 19981 recall

Recent decisions in JJF

The JJF category page

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  • K040332Polymedco Spotchem EZ Chemistry AnalyzerArkray, Inc. · 2004
  • K033734Lightcycler Instrument Version 1.2Roche Diagnostics Corp. · 20031 recall
  • K013654Precision Systems Analette Chemistry AnalyzerPrecision Systems, Inc. · 2002
  • K012966Roche Cobas Taqman AnalyzerRoche Molecular Systems, Inc. · 20023 recalls

https://510kreport.com/device/K864236 · printed Nov 4, 2026

Cite this page

510(k) Report. “K864236: Synchron CX3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K864236

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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