510(k) · Cleared
ClearedSynchron Systems Cholinesterase (Chex) Model A53722
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · DIH Colorimetry, Cholinesterase
Cleared on Feb 7, 2011 as substantially equivalent to K030045 (Olympus America, Inc., 2003) after an 82-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Feb 7, 2011
- Review
- 82 days
- Class
- Class I
- Product code
- DIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K030045 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK030045 Olympus Cholinesterase Reagent (Catalog Number OSR6114)Olympus America, Inc. · 2003
- This deviceK103373 Synchron Systems Cholinesterase (Chex) Model A53722Beckman Coulter, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K030045 | Olympus Cholinesterase Reagent (Catalog Number OSR6114) | Olympus America, Inc. | 2003 | — |
| 0 (this device) | K103373 | Synchron Systems Cholinesterase (Chex) Model A53722 | Beckman Coulter, Inc. | 2011 | — |
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 DIH? 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
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 |
|---|---|---|---|
| * | K030045 | Olympus Cholinesterase Reagent (Catalog Number OSR6114)Summary page 1…IOLYMPUS ICholinesterase (OHE) Cholinesterase (CHEX) IAMERICA, IK030045 Reagent J__ _ INC. 5.0 Description: System reagent for th… | 2003 |
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 no recall.
How does its category compare?
All DIH devicesDIH Colorimetry, Cholinesterase: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DIH
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · DIH
Too few DIH 510(k)s in any year since 2007 to give a median.
Recalls per year · DIH
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIH
1in 2024
MAUDE reports naming product code DIH, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
System reagent for the quantitative determination of Cholinesterase activity (E.C. 3.1.1.8) in human serum and plasma on Beckman Coulter Synchron CX® Pro System(s), Synchron LX® Pro System(s) and UniCel® DxC 600/800 System(s).
Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103373 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103373: Synchron Systems Cholinesterase (Chex) Model A53722.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103373
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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