510(k) · Cleared
Recalled · Class II · 2019VITROS Chemistry Products Cl- Slides
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Clinical Diagnostics · CGZ Electrode, Ion-Specific, Chloride
Cleared on Dec 16, 2016 as substantially equivalent to K990346 (Bayer Corp., 1999) after a 148-day review. Its family tree reaches back 1 generation to 1999. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 16, 2016
- Review
- 148 days
- Class
- Class II
- Product code
- CGZ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K990346 (1999). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK990346 Bayer Advia 1650 Chemistry SystemBayer Corp. · 1999 · Recalled
- This deviceK162020 VITROS Chemistry Products Cl- SlidesOrtho Clinical Diagnostics · 2016
- Descendant · cites it directly · 1 of its ownK182072 VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2…Ortho-Clinical Diagnostics, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 0 of its ownK190520 VITROS XT Chemistry Products GLU-Ca SlidesOrtho-Clinical Diagnostics, Inc. · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K990346 | Bayer Advia 1650 Chemistry System | Bayer Corp. | 1999 | 14 |
| 0 (this device) | K162020 | VITROS Chemistry Products Cl- Slides | Ortho Clinical Diagnostics | 2016 | — |
| +1 | K182072 | VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides… | Ortho-Clinical Diagnostics, Inc. | 2018 | 2 |
| +2 | K190520 | VITROS XT Chemistry Products GLU-Ca Slides | Ortho-Clinical Diagnostics, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
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 CGZ? 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 |
|---|---|---|---|
| * | K990346 | Bayer Advia 1650 Chemistry SystemSummary page 4…s Cl- slides are substantially device to which equivalent to the Siemens ADVIA® Chloride (CL) assay, equivalence is claimed cleared on May 21, 1999 (k990346). Device description The VITROS® Chemistry Products Cl- Slide assay is performed using… | 1999 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182072 | VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS… | 2018 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 10, 2019 | Class II | Z-0267-2020 | Process control | Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge. |
| Jul 11, 2018 | Class III | Z-3184-2018 | Under Investigation by firm | The slides failed to meet current claims for Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) for urine samples. The measuring range (15-300 mmol/L) for urine samples when tested with the Cl- slide is not… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All CGZ devicesCGZ Electrode, Ion-Specific, Chloride: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · CGZ
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · CGZ
Too few CGZ 510(k)s in any year since 2007 to give a median.
Recalls per year · CGZ
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CGZ
5in 2025
MAUDE reports naming product code CGZ, 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 | 1 | — | 1 | 4 |
| 2008 | 2 | — | 1 | 0 |
| 2009 | 0 | — | 1 | 1 |
| 2010 | 0 | — | 0 | 7 |
| 2011 | 0 | — | 1 | 5 |
| 2012 | 0 | — | 0 | 30 |
| 2013 | 0 | — | 0 | 42 |
| 2014 | 0 | — | 0 | 10 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 19 |
| 2019 | 0 | — | 2 | 3 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Rx. For in vitro diagnostic use only.
VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma, and urine using VITROS Chemistry and Integrated Systems. Chloride measurements are used in diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
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/K162020 · printed Nov 3, 2026
Cite this page
510(k) Report. “K162020: VITROS Chemistry Products Cl- Slides.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K162020
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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