510(k) · Cleared
ClearedSynchron Systems Cal 5 Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Instruments, Inc. · JIX Calibrator, Multi-Analyte Mixture
Cleared on Jun 3, 1997 as substantially equivalent to K926236 (Beckman Instruments, Inc., 1993) after a 57-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Jun 3, 1997
- Review
- 57 days
- Class
- Class II
- Product code
- JIX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K926236 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK926236 Beckman Anti-Streptolysin O KitBeckman Instruments, Inc. · 1993 · Recalled
- This deviceK971283 Synchron Systems Cal 5 PlusBeckman Instruments, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K926236 | Beckman Anti-Streptolysin O Kit | Beckman Instruments, Inc. | 1993 | 1 |
| 0 (this device) | K971283 | Synchron Systems Cal 5 Plus | Beckman Instruments, Inc. | 1997 | — |
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 JIX? 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 |
|---|---|---|---|
| * | K926236 | Beckman Anti-Streptolysin O KitSummary page 1…s 3.2 Classification Name (21 CFR § 862.1150) Calibrator Predicate Device(s): JN - 3 1997 SYNCHRON Systems Beckman CAL 5 Plus Beckman CAL 5 Plus Instruments, Inc. K926236/A Beckman Instruments, Inc., Section 5i0(k) Nofification 2 SYNCHRON® Systems CAL 5 Plus Summary of Safety & Effec… | 1993 |
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.
- 1 other device also cites its predicate K926236.
How does its category compare?
All JIX devicesJIX Calibrator, Multi-Analyte Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIX
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · JIX
29in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIX
7in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIX
18in 2025
MAUDE reports naming product code JIX, 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 | 6 | 53 | 2 | 140 |
| 2008 | 5 | 69 | 3 | 173 |
| 2009 | 4 | 121 | 2 | 39 |
| 2010 | 5 | 100 | 1 | 0 |
| 2011 | 7 | 77 | 2 | 9 |
| 2012 | 2 | — | 1 | 3 |
| 2013 | 4 | 50 | 0 | 24 |
| 2014 | 1 | — | 1 | 35 |
| 2015 | 3 | 29 | 0 | 4 |
| 2016 | 1 | — | 1 | 6 |
| 2017 | 0 | — | 1 | 17 |
| 2018 | 0 | — | 1 | 16 |
| 2019 | 0 | — | 1 | 12 |
| 2020 | 0 | — | 2 | 22 |
| 2021 | 0 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 7 | 13 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 0 | — | 0 | 18 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The SYNCHRON® Systems CAL 5 Plus, when used in conjunction with SYNCHRON® Systems and reagents, is intended for use in the calibration of Antistreptolysin-O (ASO-) on the SYNCHRON CX® Systems and for Antistreptolysin-O (ASO-), C-reactive protein (CRP), and Rheumatoid factor (RF) chemistries on the SYNCHRON LX™ 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/K971283 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971283: Synchron Systems Cal 5 Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971283
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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