510(k) · Cleared
ClearedSynchron CX Delta Clinical Systems, Creatinine Test Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · CGX Alkaline Picrate, Colorimetry, Creatinine
Cleared on Jun 1, 2007 as substantially equivalent to K950958 (Beckman Instruments, Inc., 1995) after a 25-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Jun 1, 2007
- Review
- 25 days
- Class
- Class II
- Product code
- CGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K950958 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK950958 Synchon CX Delta Clin Syst (CX4, CX5, CX7 Delta)Beckman Instruments, Inc. · 1995 · Recalled
- This deviceK071280 Synchron CX Delta Clinical Systems, Creatinine Test SystemsBeckman Coulter, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950958 | Synchon CX Delta Clin Syst (CX4, CX5, CX7 Delta) | Beckman Instruments, Inc. | 1995 | 4 |
| 0 (this device) | K071280 | Synchron CX Delta Clinical Systems, Creatinine Test Systems | Beckman Coulter, Inc. | 2007 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CGX? 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 CGX device
- #1 K242685 Atellica® CH Creatinine_3 (Crea3)score 12.1 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K950958 | Synchon CX Delta Clin Syst (CX4, CX5, CX7 Delta)Summary page 1…stems, claims substantial equivalence to the Beckman Coulter SYNCHRON CX Delta Clinical System currently in commercial distribution, FDA 510O(k) Number K950958. 5.0 Device Description The SYNCHRON CX Delta System determines creatinine concentration by means of the… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has a recall.
- 2 other devices also cite its predicate K950958.
How does its category compare?
All CGX devicesCGX Alkaline Picrate, Colorimetry, Creatinine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · CGX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CGX
25in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGX
2in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CGX
34in 2025
MAUDE reports naming product code CGX, 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 | 4 | 25 | 0 | 15 |
| 2008 | 0 | — | 1 | 27 |
| 2009 | 1 | — | 2 | 5 |
| 2010 | 0 | — | 2 | 5 |
| 2011 | 0 | — | 1 | 32 |
| 2012 | 1 | — | 2 | 13 |
| 2013 | 1 | — | 0 | 24 |
| 2014 | 2 | — | 0 | 13 |
| 2015 | 0 | — | 0 | 13 |
| 2016 | 1 | — | 2 | 3 |
| 2017 | 0 | — | 0 | 21 |
| 2018 | 0 | — | 0 | 14 |
| 2019 | 0 | — | 0 | 25 |
| 2020 | 0 | — | 0 | 19 |
| 2021 | 0 | — | 0 | 13 |
| 2022 | 1 | — | 0 | 23 |
| 2023 | 0 | — | 0 | 19 |
| 2024 | 2 | — | 0 | 32 |
| 2025 | 1 | — | 0 | 34 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
Beckman Coulter SYNCHRON CX Calibrators 1, 2, and 3 are to be used for calibrating SYNCHRON CX Delta, CX®CE, and CX PRO Systems only.
CRE3 reagent, in conjunction with SYNCHRON CX® Delta Systems and SYNCHRON CX®Calibrators 1, 2 and 3 is intended for the quantitative determination of Creatinine (CRE3) in human serum, plasma or urine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071280 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071280: Synchron CX Delta Clinical Systems, Creatinine Test Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071280
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026