510(k) · Cleared
ClearedYumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Horiba Abx Sas · CJY Azo Dye, Calcium
Cleared on Jul 26, 2019 as substantially equivalent to K123171 (Horiba Abx Sas, 2013) and 1 other predicate after a 63-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Jul 26, 2019
- Review
- 63 days
- Class
- Class II
- Product code
- CJY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K933930 (1994). 24 ancestors in all, the oldest K801297 (1980). No later device cites it as a predicate yet.
- Root · 5 generations backK933930 Puritan-Bennett Companion 550 Liquid Oxygen Portable UnitPuritan Bennett Corp. · 1994
- 4 generations backK993220 Puritan-Bennett Helios Portable Liquid Oxygen SystemPuritan Bennett Corp. · 1999
- 3 generations backK041122 Precision Liquid Oxygen SystemPrecision Medical, Inc. · 2004 · Recalled
- 2 generations backK052007 Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module)Horiba Abx · 2005 · Recalled
- 1 generation backK110530 Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N…Horiba Abx Sas · 2012 · Recalled
- This deviceK191396 Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine JaffeHoriba Abx Sas · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K933930 | Puritan-Bennett Companion 550 Liquid Oxygen Portable Unit | Puritan Bennett Corp. | 1994 | — |
| −4 | K993220 | Puritan-Bennett Helios Portable Liquid Oxygen System | Puritan Bennett Corp. | 1999 | — |
| −3 | K041122 | Precision Liquid Oxygen System | Precision Medical, Inc. | 2004 | 1 |
| −2 | K052007 | Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module) | Horiba Abx | 2005 | 6 |
| −1 | K110530 | Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N Control; Abx… | Horiba Abx Sas | 2012 | 3 |
| 0 (this device) | K191396 | Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe | Horiba Abx Sas | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 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 CJY? 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 CJY device
- #1 K244042 Calcium2score 9.4 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K123171 | Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra Multical, Abx Pentra…Summary page 6…number ABX Pentra Calcium AS CP Yumizen C1200 On ABX Pentra 400 / Pentra HORIBA ABX SAS K123171 Calcium AS C400 ABX Pentra Creatinine 120 CP… | 2013 |
| * | K110530 | Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N Control; Abx Pentra P…Summary page 6…RIBA ABX SAS K123171 Calcium AS C400 ABX Pentra Creatinine 120 CP K110530 Yumizen C1200 On ABX Pentra 400/ Pentra HORIBA ABX SAS Creatinine Jaffé… | 2012 |
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?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- 6 of the 24 ancestors have a recall of any class.
- 1 other device also cites its predicate K123171.
How does its category compare?
All CJY devicesCJY Azo Dye, Calcium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · CJY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CJY
Too few CJY 510(k)s in any year since 2007 to give a median.
Recalls per year · CJY
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CJY
59in 2025
MAUDE reports naming product code CJY, 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 | 2 | — | 0 | 3 |
| 2008 | 2 | — | 0 | 4 |
| 2009 | 1 | — | 0 | 8 |
| 2010 | 0 | — | 0 | 10 |
| 2011 | 0 | — | 0 | 9 |
| 2012 | 1 | — | 0 | 5 |
| 2013 | 1 | — | 4 | 8 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 1 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 26 |
| 2018 | 1 | — | 2 | 21 |
| 2019 | 1 | — | 0 | 29 |
| 2020 | 0 | — | 0 | 33 |
| 2021 | 0 | — | 0 | 24 |
| 2022 | 0 | — | 1 | 17 |
| 2023 | 0 | — | 0 | 29 |
| 2024 | 0 | — | 0 | 34 |
| 2025 | 1 | — | 0 | 59 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Yumizen C1200 Calcium AS reagent is a diagnostic reagent for quantitative in vitro determination of calcium in human serum, plasma and urine based on colorimetric method, using the clinical chemistry analyzer. Measurement of calcium is used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). Yumizen C1200 Creatinine Jaffé reagent is a…
Read the full statement (117 words)
Yumizen C1200 Calcium AS reagent is a diagnostic reagent for quantitative in vitro determination of calcium in human serum, plasma and urine based on colorimetric method, using the clinical chemistry analyzer. Measurement of calcium is used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Yumizen C1200 Creatinine Jaffé reagent is a diagnostic reagent for quantitative in vitro determination of Creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffé method). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
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/K191396 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191396: Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191396
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