510(k) · Cleared
ClearedSynchron CX Systems Prealbumin Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · JIS Calibrator, Primary
Cleared on Feb 3, 2000 as substantially equivalent to K994168 (Beckman Coulter, Inc., 2000) and 1 other predicate after a 55-day review. Its family tree reaches back 2 generations to 1986.
- Decided
- Feb 3, 2000
- Review
- 55 days
- Class
- Class II
- Product code
- JIS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K854811 (1986). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 JIS? 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? (2)
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 |
|---|---|---|---|
| * | K994168 | Synchron LX Systems Prealbumin Calibrator Cleared while this submission was under review Summary page 1…1999 Device Name(s): 3.1 Proprietary Names SYNCHRON® CX Systems Prealbumin Calibrator 3.2 Classification Name Calibrator, (21 CFR §862.1150) Predicate Device(s]}: K 994168 Reagent SYNCHRON Systems Predicate Manufacturer Docket Number PAB Calibrator Immunochemistry Systems CAL 3 SYNCHRON® Systems… | 2000 |
| * | K854811 | Ics Pab Prealbumin Reagent Test KitSummary page 1…K 994168 Reagent SYNCHRON Systems Predicate Manufacturer Docket Number PAB Calibrator Immunochemistry Systems CAL 3 SYNCHRON® Systems Beckman Beckman Coulter, Inc. K854811 Description: The SYNCHRON CX Systems Prealbumin Calibrator Set is a six level ready-to-use human serum-based liquid calibrator… | 1986 |
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?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 14.0 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All JIS devicesJIS Calibrator, Primary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIS
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · JIS
Too few JIS 510(k)s in any year since 2007 to give a median.
Recalls per year · JIS
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIS
1in 2024
MAUDE reports naming product code JIS, 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 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 2 | 5 |
| 2012 | 1 | — | 1 | 5 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 1 | 1 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 1 | 7 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 1 | 1 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 0 | — | 1 | 11 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SYNCHRON® CX Systems Prealbumin Calibrator, used in conjunction with SYNCHRON® Systems Prealbumin reagent, is intended for use on Beckman’s SYNCHRON CX Systems for the calibration of prealbumin test systems.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K994169 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994169: Synchron CX Systems Prealbumin Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994169
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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