510(k) · Cleared
Recalled · Class II · 2012Olympus Creatinine Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Corp. · CGX Alkaline Picrate, Colorimetry, Creatinine
Cleared on Nov 16, 1993 after a 69-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it. It has been recalled once.
- Decided
- Nov 16, 1993
- Review
- 69 days
- Class
- Class II
- Product code
- CGX
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK934361 Olympus Creatinine ReagentOlympus Corp. · 1993
- Descendant · cites it directly · 1 of its ownK200898 Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas…Medicon Hellas S.A · 2021
- Descendant · cites it directly · 1 of its ownK110530 Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N…Horiba Abx Sas · 2012 · Recalled
- Descendant · 2 generations on · 0 of its ownK251157 Core MetabolicTruvian Health · 2026
- Descendant · 2 generations on · 0 of its ownK191396 Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine JaffeHoriba Abx Sas · 2019
Most influential descendants
Showing 4 of 4 · See all- K200898Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon…Medicon Hellas S.A · 2021 · cites it directly1descendant
- K110530Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N Control; Abx Pentra P…Horiba Abx Sas · 2012 · cites it directly1descendant
- K251157Core MetabolicTruvian Health · 2026 · 2 generations on0descendants
- K191396Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine JaffeHoriba Abx Sas · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K934361 | Olympus Creatinine Reagent | Olympus Corp. | 1993 | — |
| +1 | K200898 | Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine… | Medicon Hellas S.A | 2021 | — |
| +1 | K110530 | Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N Control; Abx… | Horiba Abx Sas | 2012 | 3 |
| +2 | K251157 | Core Metabolic | Truvian Health | 2026 | — |
| +2 | K191396 | Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe | Horiba Abx Sas | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CGX? 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 CGX device
- #1 K242685 Atellica® CH Creatinine_3 (Crea3)score 12.1 · 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 28, 2012 | Class II | Z-0958-2013 | Labeling design | Beckman Coulter is including additional information and instructions in the Creatinine (OSR6x78) IFU and Setting Sheet, relating to calibration stability and quality control frequency to assure product performance. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K200898 (Medicon Hellas S.A, 2021) has gone furthest, with 1 descendant of its own.
How does its category compare?
All CGX devicesCGX Alkaline Picrate, Colorimetry, Creatinine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CGX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CGX
25in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGX
2in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CGX
34in 2025
MAUDE reports naming product code CGX, 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 | 4 | 25 | 0 | 15 |
| 2008 | 0 | — | 1 | 27 |
| 2009 | 1 | — | 2 | 5 |
| 2010 | 0 | — | 2 | 5 |
| 2011 | 0 | — | 1 | 32 |
| 2012 | 1 | — | 2 | 13 |
| 2013 | 1 | — | 0 | 24 |
| 2014 | 2 | — | 0 | 13 |
| 2015 | 0 | — | 0 | 13 |
| 2016 | 1 | — | 2 | 3 |
| 2017 | 0 | — | 0 | 21 |
| 2018 | 0 | — | 0 | 14 |
| 2019 | 0 | — | 0 | 25 |
| 2020 | 0 | — | 0 | 19 |
| 2021 | 0 | — | 0 | 13 |
| 2022 | 1 | — | 0 | 23 |
| 2023 | 0 | — | 0 | 19 |
| 2024 | 2 | — | 0 | 32 |
| 2025 | 1 | — | 0 | 34 |
| 2026 | 1 | — | 1 | — |
https://510kreport.com/device/K934361 · printed Nov 6, 2026
Cite this page
510(k) Report. “K934361: Olympus Creatinine Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K934361
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026