510(k) · Cleared
ClearedClinical Chloride Analyzer, Chloride Test System, Sweat Chloride Analyzer, Chloridometer, Chloride Coulometric
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wescor, Inc. · JFS Coulometric, Chloride
Cleared on Mar 27, 2013 as substantially equivalent to K760394 (Bulcher Instruments, 1976) after a 279-day review. Its family tree reaches back 1 generation to 1976.
- Decided
- Mar 27, 2013
- Review
- 279 days
- Class
- Class II
- Product code
- JFS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K760394 (1976). No later device cites it as a predicate yet.
- Root · 1 generation backK760394 Reagent, Chloridometer AcidBulcher Instruments · 1976
- This deviceK121823 Clinical Chloride Analyzer, Chloride Test System, Sweat Chloride…Wescor, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K760394 | Reagent, Chloridometer Acid | Bulcher Instruments | 1976 | — |
| 0 (this device) | K121823 | Clinical Chloride Analyzer, Chloride Test System, Sweat Chloride Analyzer… | Wescor, Inc. | 2013 | — |
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 JFS? 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 |
|---|---|---|---|
| * | K760394 | Reagent, Chloridometer AcidSummary page 2…e Instrument 5 10(k) Number Buchler Instruments (Labconco), Chioridometer@. K760394 Substantial Equivalence: The Wescor CHLOROCHEK M Chioridometer@ test system (Model 3400 w… | 1976 |
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 JFS devicesJFS Coulometric, Chloride: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · JFS
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · JFS
Too few JFS 510(k)s in any year since 2007 to give a median.
Recalls per year · JFS
No recall names JFS since 2007.
Adverse event reports per year · JFS
No MAUDE report names JFS since 2007.
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 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 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 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Wescor ChloroChek Chloridometer test system is intended for the quantitative in vitro diagnostic determination of chloride in human sweat using the principle of coulometric titration. Sweat chloride measurements are used in the diagnosis of Cystic Fibrosis. It is for use in Clinical Laboratory settings. The Wescor ChloroChek Chloridometer test system consists of the ChloroChek Chloridometer and the ChloroChek Reagent Set. The ChloroChek Reagent Set…
Read the full statement (132 words)
The Wescor ChloroChek Chloridometer test system is intended for the quantitative in vitro diagnostic determination of chloride in human sweat using the principle of coulometric titration. Sweat chloride measurements are used in the diagnosis of Cystic Fibrosis. It is for use in Clinical Laboratory settings. The Wescor ChloroChek Chloridometer test system consists of the ChloroChek Chloridometer and the ChloroChek Reagent Set.
The ChloroChek Reagent Set (SS-248) is to be used on the ChloroChek. It is used as the titration matrix during the titration process.
The 100 mmol/L NaCl/H2O Standard Solution (SS-251), is to be used on the ChloroChek. It is used as a calibration verifier, and quality control solution.
The Wescor Sweat Controls (SS-150), levels #1,#2, and #3, are to be used on the ChloroChek. They are used as quality control solutions.
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/K121823 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121823: Clinical Chloride Analyzer, Chloride Test System, Sweat Chloride Analyzer, Chloridometer, Chloride Coulometric.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121823
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)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026