510(k) · Cleared
ClearedBS-400 Chemistry Analyzer, CLC 720 Chemistry Analyzer
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 Mar 23, 2012 as substantially equivalent to K904219 (Beckman, 1990) and 2 other predicates after a 219-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it.
- Decided
- Mar 23, 2012
- Review
- 219 days
- Class
- Class II
- Product code
- CFR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K953239 (1995). 6 ancestors in all, the oldest K904219 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK953239 Boehringer Mannheim/Hitachi 917 AnalyzerBoehringer Mannheim Corp. · 1995 · Recalled
- 1 generation backK072018 BS-200 Chemistry Analyzer, Mode BS-200Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · Recalled
- This deviceK112377 BS-400 Chemistry Analyzer, CLC 720 Chemistry AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2012
- Descendant · cites it directly · 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 1 of 1 · See all- K140690BS-480 Chemistry Analyzer, BS-490 Chemistry Analyzer, CLC720I Chemistry AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953239 | Boehringer Mannheim/Hitachi 917 Analyzer | Boehringer Mannheim Corp. | 1995 | 18 |
| −1 | K072018 | BS-200 Chemistry Analyzer, Mode BS-200 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | 1 |
| 0 (this device) | K112377 | BS-400 Chemistry Analyzer, CLC 720 Chemistry Analyzer | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2012 | — |
| +1 | 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 |
|---|---|---|
| 1990 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 |
|---|---|---|---|
| * | K904219 | Synchron CX 7 Clinical AnalyzerSummary page 2…27 510(do Summary 7SCGE, Class 11 7SJGS, Class 11 Legally Marketed Predicate Device: K904219 SYNCHRON CX7, BECKMAN K072018 BS-200 Chemistry Analyzer, Mindray K970664 GLUCOSE REAGENT, DERMA MEDIA LAB., I… | 1990 |
| * | K072018 | BS-200 Chemistry Analyzer, Mode BS-200Summary page 2…7SCGE, Class 11 7SJGS, Class 11 Legally Marketed Predicate Device: K904219 SYNCHRON CX7, BECKMAN K072018 BS-200 Chemistry Analyzer, Mindray K970664 GLUCOSE REAGENT, DERMA MEDIA LAB., INC. Description: The BS-400/CLC 72… | 2008 |
| * | K970664 | Glucose ReagentSummary page 2…7SJGS, Class 11 Legally Marketed Predicate Device: K904219 SYNCHRON CX7, BECKMAN K072018 BS-200 Chemistry Analyzer, Mindray K970664 GLUCOSE REAGENT, DERMA MEDIA LAB., INC. Description: The BS-400/CLC 720 Chemistry Analyzer is an automated clinical chem… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140690 | BS-480 Chemistry Analyzer, BS-490 Chemistry Analyzer, CLC720I Chemistry Analyzer | 2014 | 0 |
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 17 years and passes through 2 companies; a new generation was cleared every 12.4 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K140690 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2014) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K904219.
How does its category compare?
All CFR devicesCFR Hexokinase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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-400/CLC 720 Chemistry Analyzers are designed for clinical laboratory use, making direct quantitative measurements of Na+ (sodium), K+ (potassium), CI- (chloride) in serum, plasma and urine samples and Glucose in serum samples plasma and urine 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…
Read the full statement (134 words)
The BS-400/CLC 720 Chemistry Analyzers are designed for clinical laboratory use,
making direct quantitative measurements of Na+ (sodium), K+ (potassium), CI-
(chloride) in serum, plasma and urine samples and Glucose in serum samples plasma
and urine 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K112377 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112377: BS-400 Chemistry Analyzer, CLC 720 Chemistry Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112377
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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