510(k) Report

510(k) · Cleared

Recalled · 2003

Synchron CX Pro Clinical Systems, Model CX4 Pro, CX5 Pro, CX7 Pro, CX9 Pro

K011465510(k) SpecialCleared Jun 8, 200125-day reviewClass II21 CFR 862.3030Recalls 1

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

Beckman Coulter, Inc. · LDP Colorimetry, Acetaminophen

Cleared on Jun 8, 2001 after a 25-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled once.

Decided
Jun 8, 2001
Review
25 days
Class
Class II
Product code
LDP
Recalls
1
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared200020052010201520202025
  1. This deviceK011465 Synchron CX Pro Clinical Systems, Model CX4 Pro, CX5 Pro, CX7 Pro…Beckman Coulter, Inc. · 2001
  2. Descendant · cites it directly · 0 of its ownK042270 Stat K in Vitro Diagnostic Test SystemStat Chem, Inc. · 2004

Most influential descendants

Showing 1 of 1 · See all
  • K042270Stat K in Vitro Diagnostic Test SystemStat Chem, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011465Synchron CX Pro Clinical Systems, Model CX4 Pro, CX5 Pro, CX7 Pro, CX9 ProBeckman Coulter, Inc.2001—
+1K042270Stat K in Vitro Diagnostic Test SystemStat Chem, Inc.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
FIG. 1 — Lineage of K011465, 2001–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 LDP? 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 LDP device

  1. #1 K261364 Atellica CH Acetaminophen 2 (ACTM)score 11.7 · 1 generation · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) 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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K042270Stat K in Vitro Diagnostic Test SystemStat Chem, Inc.20040

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

Recalls of this device

DateClassRecallRoot causeReason
Sep 29, 2003Not classifiedZ-0067-04OtherMotor driver boards may contain wrong type of microchip which does not have obstruction detection feature.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K042270 (Stat Chem, Inc., 2004) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LDP devices

LDP Colorimetry, Acetaminophen: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LDP

1in 2022

2009: 12010: 12011: 12019: 12022: 12026 (partial year): 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LDP

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

Recalls per year · LDP

1in 2013

2007: 12008: 12010: 22013: 1
2007high 2 (2010) · low 0 (2009)2026

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

Adverse event reports per year · LDP

3in 2025

2007: 62008: 22009: 12010: 52011: 52012: 22013: 42014: 22015: 12016: 12017: 32021: 22023: 12024: 12025: 3
2007high 6 (2007) · low 0 (2018)2025

MAUDE reports naming product code LDP, 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—16
20080—12
20091—01
20101—25
20111—05
20120—02
20130—14
20140—02
20150—01
20160—01
20170—03
20180—00
20191—00
20200—00
20210—02
20221—00
20230—01
20240—01
20250—03
20261—0—

More from Beckman Coulter, Inc.

456 FDA decisions under this applicant name. See the company

  • K262597Access BNP IIBeckman Coulter, Inc. · 2026
  • K261109Access MeMed BVBeckman Coulter, Inc. · 2026
  • K262109Access NT-proBNPBeckman Coulter, Inc. · 2026
  • K252169Access BNP IIBeckman Coulter, Inc. · 2026
  • K254059Access anti-HBc IgMBeckman Coulter, Inc. · 2026

Recent decisions in LDP

The LDP category page

  • K261364Atellica CH Acetaminophen 2 (ACTM)Siemens Healthcare Diagnostics, Inc. · 2026
  • K202644AcetaminophenSekisui Diagnostics P.E.I., Inc. · 2022
  • K180835SEKURE Acetaminophen L3K AssaySekisui Diagnostics P.E.I., Inc. · 2019
  • K110726Roche Acetaminophen AssayRoche Diagnostics · 20111 recall
  • K100200Advia Chemistry Acetaminophen Reagent, Model Ref 07989138Siemens Healthcare Diagnostics · 20101 recall

https://510kreport.com/device/K011465 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011465: Synchron CX Pro Clinical Systems, Model CX4 Pro, CX5 Pro, CX7 Pro, CX9 Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011465

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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