510(k) · Cleared
ClearedBiolis 12I
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tokyo Boeki Medisys, Inc. · CEM Electrode, Ion Specific, Potassium
Cleared on Mar 23, 2012 as substantially equivalent to K042169 (Stanbio Laboratory, 2005) and 1 other predicate after a 394-day review. Its family tree reaches back 2 generations to 1985.
- Decided
- Mar 23, 2012
- Review
- 394 days
- Class
- Class II
- Product code
- CEM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K851172 (1985). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K851172 | Cobas Mira | Roche Diagnostic Systems, Inc. | 1985 | — |
| −1 | K040958 | Prestige Models 24I and 400 and MGC Model 240 | Tokyo Boeki Medical System, Ltd. | 2005 | — |
| 0 (this device) | K110520 | Biolis 12I | Tokyo Boeki Medisys, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2005 | 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 |
|---|---|---|---|
| * | K042169 | Stanbio Laboratory Sirrus Clinical Chemistry AnalyzerSummary page 3…New Device Predicate ______________ Biolis 12i Sirrus(K042169) General System Principle Discrete, single line random Discrete, random access,… | 2005 |
| * | K040958 | Prestige Models 24I and 400 and MGC Model 240Summary page 2…ns using photometry and electrolytes using identical ion selective electrode modules In addition, substantial equivalence has been demonstrated between the Prestige 24i (K040958) and -2- Tokyo Boeki… | 2005 |
| † | K971467 | Synchron CX Systems Glucose Reagent (Glu) | 1997 |
| † | K070207 | Multi-Analyte Chemistry Calibrator | 2007 |
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 27 years and passes through 3 companies; a new generation was cleared every 19.8 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All CEM devicesCEM Electrode, Ion Specific, Potassium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
The Biolis 12i is a discrete photometric chemistry analyzer with ion-selective electrode (ISE), with direct quantitative measurement of sodium, potassium, chloride, and glucose in serum. It is a device intended for the in-vitro, spectrophotometric determination of general chemistry assays for clinical use. The Biolis 12i includes an optional Ion Selective Electrode (ISE) module for the measurement of sodium, potassium and chloride in serum. The Biolis…
Read the full statement (172 words)
The Biolis 12i is a discrete photometric chemistry analyzer with ion-selective electrode (ISE), with direct quantitative measurement of sodium, potassium, chloride, and glucose in serum. It is a device intended for the in-vitro, spectrophotometric determination of general chemistry assays for clinical use. The Biolis 12i includes an optional Ion Selective Electrode (ISE) module for the measurement of sodium, potassium and chloride in serum. The Biolis 12i is not for Point-Of-Care testing: It is for vitro diagnostic use only.
Sodium measurements are used in the diagnosis and treatment diseases involving electrolyte imbalance.
Potassium measurements monitor electrolyte balance and in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders.
The Biolis 12i analyzer with glucose hexokinase assay is intended to measure glucose quantitatively in human serum. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemnia, and idiopathic glycemia, and of the pancreatic islet cell carcinoma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110520 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110520: Biolis 12I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110520
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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