510(k) · Cleared
Recalled · Class II · 2019Vitros Chemistry Products K+ Slides and Calibrator Kit 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · CEM Electrode, Ion Specific, Potassium
Cleared on Dec 7, 2007 as substantially equivalent to K961115 (Johnson & Johnson Clinical Diagnostics, Inc., 1996) and 1 other predicate after a 29-day review. Its family tree reaches back 3 generations to 1999. 3 later devices descend from it. It has been recalled once.
- Decided
- Dec 7, 2007
- Review
- 29 days
- Class
- Class II
- Product code
- CEM
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K984303 (1999). 5 ancestors in all, the oldest K800054 (1980). 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK984303 Vitros Chemistry Products Magnetic HDL-Cholesterol ReagentOrtho-Clinical Diagnostics, Inc. · 1999
- 2 generations backK012593 Vitros Chemistry Products Magnetic HDL-Cholesterol Reagent, Vitros…Ortho-Clinical Diagnostics, Inc. · 2001 · Recalled
- 1 generation backK071801 Vitros Chemistry Products CI-Slides, Calibrator Kit 2, Model (S)…Ortho-Clinical Diagnostics, Inc. · 2007 · Recalled
- This deviceK073157 Vitros Chemistry Products K+ Slides and Calibrator Kit 2Ortho-Clinical Diagnostics, Inc. · 2007
- Descendant · cites it directly · 2 of its ownK081411 Vitros Chemistry Product NA+ Slides; Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 1 of its ownK091861 Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT…Ortho-Clinical Diagnostics, Inc. · 2009
- Descendant · 3 generations on · 0 of its ownK093611 Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products…Ortho-Clinical Diagnostics, Inc. · 2010
Most influential descendants
Showing 3 of 3 · See all- K081411Vitros Chemistry Product NA+ Slides; Vitros Chemistry Products Calibrator Kit 2Ortho-Clinical Diagnostics, Inc. · 2008 · cites it directly2descendants
- K091861Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT Calibrator Kit, Model…Ortho-Clinical Diagnostics, Inc. · 2009 · 2 generations on1descendant
- K093611Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products DT Calibrator Kit…Ortho-Clinical Diagnostics, Inc. · 2010 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K984303 | Vitros Chemistry Products Magnetic HDL-Cholesterol Reagent | Ortho-Clinical Diagnostics, Inc. | 1999 | — |
| −2 | K012593 | Vitros Chemistry Products Magnetic HDL-Cholesterol Reagent, Vitros Chemistry… | Ortho-Clinical Diagnostics, Inc. | 2001 | 1 |
| −1 | K071801 | Vitros Chemistry Products CI-Slides, Calibrator Kit 2, Model (S) 844-5207… | Ortho-Clinical Diagnostics, Inc. | 2007 | 4 |
| 0 (this device) | K073157 | Vitros Chemistry Products K+ Slides and Calibrator Kit 2 | Ortho-Clinical Diagnostics, Inc. | 2007 | — |
| +1 | K081411 | Vitros Chemistry Product NA+ Slides; Vitros Chemistry Products Calibrator Kit 2 | Ortho-Clinical Diagnostics, Inc. | 2008 | 4 |
| +2 | K091861 | Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT Calibrator… | Ortho-Clinical Diagnostics, Inc. | 2009 | — |
| +3 | K093611 | Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products DT… | Ortho-Clinical Diagnostics, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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 CEM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CEM device
- #1 K253491 ISE indirect K for Gen.2; ISE indirect Na for…score 11.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K961115 | Ektachem Clinical Chemistry Slide Potassium (K+)Summary page 1…(current slide) and VITROS Chemistry Products Calibrator Kit 2. The FDA cleared the VITROS Chemistry Products K' Slides on May 7, 1996 (K961 115) under the product name EKTACHEM Clinical Chemistry Slide Potassium (K4 ). With the purchase of KODAK Clinical P… | 1996 |
| * | K071801 | Vitros Chemistry Products CI-Slides, Calibrator Kit 2, Model (S) 844-5207, 166-2659Summary page 1…ITROS Chemistry Products K' Slides. The most recent FDA clearance for the VITROS Chemistry Products Calibrator Kit 2 was July 20, 2007 (K07 180 1). Continuned on next page 510(k) Summa… | 2007 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081411 | Vitros Chemistry Product NA+ Slides; Vitros Chemistry Products Calibrator Kit 2 | 2008 | 2 |
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-0269-2020 | Process control | Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 1 company; a new generation was cleared every 2.6 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K081411 (Ortho-Clinical Diagnostics, Inc., 2008) has gone furthest, with 2 descendants of its own.
How does its category compare?
All CEM devicesCEM Electrode, Ion Specific, Potassium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · CEM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CEM
180in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CEM
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CEM
29in 2025
MAUDE reports naming product code CEM, 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 | — | 0 | 66 |
| 2008 | 0 | — | 1 | 245 |
| 2009 | 1 | — | 0 | 79 |
| 2010 | 3 | 195 | 12 | 113 |
| 2011 | 3 | 74 | 6 | 126 |
| 2012 | 4 | 180 | 0 | 45 |
| 2013 | 0 | — | 0 | 37 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 0 | — | 1 | 6 |
| 2017 | 0 | — | 0 | 32 |
| 2018 | 0 | — | 0 | 13 |
| 2019 | 0 | — | 1 | 25 |
| 2020 | 1 | — | 3 | 27 |
| 2021 | 0 | — | 1 | 18 |
| 2022 | 0 | — | 0 | 16 |
| 2023 | 2 | — | 2 | 30 |
| 2024 | 0 | — | 0 | 42 |
| 2025 | 1 | — | 4 | 29 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
For in vitro diagnostic use only. VITROS K+ Slides quantitatively measure potassium (K + ) concentration in serum, plasma, and urine. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases and conditions characterized by low or high blood potassium levels.
For in vitro diagnostic use only. VITROS Calibrator Kit 2 is used to calibrate the VITROS Chemistry Systems for the quantitative measurement of CHOL, Ci, ECO2, HIDLC, K*, Nat, and TRIG.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073157 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073157: Vitros Chemistry Products K+ Slides and Calibrator Kit 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073157
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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