510(k) · Cleared
Recalled · Class II · 2012BS-200 Chemistry Analyzer, Mode BS-200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · CFR Hexokinase, Glucose
Cleared on Feb 1, 2008 as substantially equivalent to K953239 (Boehringer Mannheim Corp., 1995) and 2 other predicates after a 193-day review. Its family tree reaches back 1 generation to 1995. 3 later devices descend from it. It has been recalled once.
- Decided
- Feb 1, 2008
- Review
- 193 days
- Class
- Class II
- Product code
- CFR
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 1 generation to K953239 (1995). 3 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK953239 Boehringer Mannheim/Hitachi 917 AnalyzerBoehringer Mannheim Corp. · 1995 · Recalled
- This deviceK072018 BS-200 Chemistry Analyzer, Mode BS-200Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- Descendant · cites it directly · 1 of its ownK112377 BS-400 Chemistry Analyzer, CLC 720 Chemistry AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK160370 BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK140690 BS-480 Chemistry Analyzer, BS-490 Chemistry Analyzer, CLC720I…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2014
Most influential descendants
Showing 3 of 3 · See all- K112377BS-400 Chemistry Analyzer, CLC 720 Chemistry AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2012 · cites it directly1descendant
- K160370BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2016 · cites it directly0descendants
- K140690BS-480 Chemistry Analyzer, BS-490 Chemistry Analyzer, CLC720I Chemistry AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953239 | Boehringer Mannheim/Hitachi 917 Analyzer | Boehringer Mannheim Corp. | 1995 | 18 |
| 0 (this device) | K072018 | BS-200 Chemistry Analyzer, Mode BS-200 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| +1 | K112377 | BS-400 Chemistry Analyzer, CLC 720 Chemistry Analyzer | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2012 | — |
| +1 | K160370 | BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016 | 2 |
| +2 | K140690 | BS-480 Chemistry Analyzer, BS-490 Chemistry Analyzer, CLC720I Chemistry Analyzer | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 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 CFR? 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 CFR device
- #1 K253490 Glucose HK Gen.3; ONLINE DAT Methadone II…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? (3)
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 |
|---|---|---|---|
| * | K953239 | Boehringer Mannheim/Hitachi 917 AnalyzerSummary page 2…Page I of 5 510 (k) Summary Legally Marketed Predicate Device: K953239 Boehringer Mannheim/Hitachi 917 Analyzer K000926 EasyElectroLyte/RapidLyte Na/K/CI Analyzer K002199 Liquid G… | 1995 |
| * | K000926 | Easyelectrolyte Analyzer and Rapidlyte AnalyzerSummary page 2…Page I of 5 510 (k) Summary Legally Marketed Predicate Device: K953239 Boehringer Mannheim/Hitachi 917 Analyzer K000926 EasyElectroLyte/RapidLyte Na/K/CI Analyzer K002199 Liquid Glucose (Hexokinase) Reagent Set Description: The BS-20… | 2000 |
| * | K002199 | Modification to Liquid Glucose (Hexokinase) Reagent SetSummary page 2…= 510 (k) Summary Legally Marketed Predicate Device: K953239 Boehringer Mannheim/Hitachi 917 Analyzer K000926 EasyElectroLyte/RapidLyte Na/K/CI Analyzer K002199 Liquid Glucose (Hexokinase) Reagent Set Description: The BS-200 Chemistry Analyzer is an automated clinical chemistry an… | 2000 |
What descends from it? (3)
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 |
|---|---|---|---|---|
| Nov 28, 2012 | Class II | Z-0977-2013 | Device Design | An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All CFR devicesCFR Hexokinase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · CFR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CFR
115in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CFR
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CFR
16in 2025
MAUDE reports naming product code CFR, 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 | 1 |
| 2008 | 5 | 182 | 7 | 2 |
| 2009 | 3 | 101 | 1 | 7 |
| 2010 | 0 | — | 0 | 11 |
| 2011 | 3 | 316 | 0 | 43 |
| 2012 | 4 | 115 | 1 | 49 |
| 2013 | 1 | — | 0 | 36 |
| 2014 | 1 | — | 1 | 2 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 2 | — | 1 | 1 |
| 2017 | 1 | — | 0 | 13 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 1 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 29 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 1 | — | 0 | 16 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The BS-200 Chemistry Analyzer is designed for clinical laboratory use, making direct quantitative measurements of Na+ (sodium), K+ (potassium), Cl-(chloride) in serum, plasma and urine samples and Glucose in serum samples. Additionally, other various chemistry assays may be adaptable to the analyzer depending on the reagent used to induce a photometric reaction. Sodium measurements are used in the diagnosis and treatment diseases involving electrolyte…
Read the full statement (128 words)
The BS-200 Chemistry Analyzer is designed for clinical laboratory use, making direct quantitative measurements of Na+ (sodium), K+ (potassium), Cl-(chloride) in serum, plasma and urine samples and Glucose in serum samples. Additionally, other various chemistry assays may be adaptable to the analyzer depending on the reagent used to induce a photometric reaction.
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.
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072018 · printed Nov 3, 2026
Cite this page
510(k) Report. “K072018: BS-200 Chemistry Analyzer, Mode BS-200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K072018
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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