510(k) · Cleared
ClearedCDS LTX Control Latex Particle Suspension and Primer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clinical Diagnostic Solutions, Inc. · KRX Calibrator For Cell Indices
Cleared on Dec 20, 1999 after a 74-day review. The FDA summary names no predicate by number.
- Decided
- Dec 20, 1999
- Review
- 74 days
- Class
- Class II
- Product code
- KRX
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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 KRX? 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?
The FDA summary names no predicate by number.
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.
How does its category compare?
All KRX devicesKRX Calibrator For Cell Indices: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KRX
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · KRX
Too few KRX 510(k)s in any year since 2007 to give a median.
Recalls per year · KRX
No recall names KRX since 2007.
Adverse event reports per year · KRX
1in 2013
MAUDE reports naming product code KRX, 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 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 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 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
CDS LTX-Control Latex Particle Suspension is intended to serve as a calibration standard for the d.c. impedance, r.f impedance and optical light scatter parameters of the VCS module of Coulter® Models STKS, MAXM and GeneS Hematology Analyzer systems. Models STKS and MAXM analyzers equipped with 5-part differential capability only require aspiration of the CDS LTX-Control Latex Particle Suspension through the secondary mode aspiration inlet with the…
Read the full statement (104 words)
CDS LTX-Control Latex Particle Suspension is intended to serve as a calibration
standard for the d.c. impedance, r.f impedance and optical light scatter parameters of the
VCS module of Coulter® Models STKS, MAXM and GeneS Hematology Analyzer
systems. Models STKS and MAXM analyzers equipped with 5-part differential
capability only require aspiration of the CDS LTX-Control Latex Particle Suspension
through the secondary mode aspiration inlet with the analyzer set to function F55. STKS
and Gene$S analyzers equipped with 5-part differential and reticulocyte capability require
aspiration of the CDS LTX-Control Latex Particle Suspension through the secondary
mode aspiration inlet with the analyzer set to function F57.
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/K993375 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993375: CDS LTX Control Latex Particle Suspension and Primer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993375
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026