510(k) · Cleared
Recalled · Class II · 2019BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 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. · JGS Electrode, Ion Specific, Sodium
Cleared on Jun 9, 2016 as substantially equivalent to K072018 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2008) after a 120-day review. Its family tree reaches back 2 generations to 1995. It has been recalled 2 times.
- Decided
- Jun 9, 2016
- Review
- 120 days
- Class
- Class II
- Product code
- JGS
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K953239 (1995). 4 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK160370 BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2016
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) | K160370 | BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 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 JGS? 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 JGS device
- #1 K252475 ABL90 FLEX PLUS Systemscore 12.2 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K072018 | BS-200 Chemistry Analyzer, Mode BS-200Summary page 5…0 (k) Summary 75CEM, Class Ⅱ 75CGZ, Class Ⅱ 75JGS, Class Ⅱ Legally Marketed Predicate Device: K072018 BS-200 Chemistry Analyzer, SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD K972671 BUN (LIQUID) REAGENT SET, POINTE SCIENTIFIC… | 2008 |
| † | K972671 | Bun (Liquid) Reagent Set | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 9, 2019 | Class II | Z-0920-2020 | Nonconforming Material/Component | The gas spring on the front and rear protective cover may fail. There is a low risk of injury to the user resulting from failure of the gas spring. Injury may include impact to the arms, hands or fingers. |
| Dec 9, 2019 | Class II | Z-0921-2020 | Nonconforming Material/Component | The gas spring on the front and rear protective cover may fail. There is a low risk of injury to the user resulting from failure of the gas spring. Injury may include impact to the arms, hands or fingers. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 12.4 years on median.
- 3 of the 4 ancestors have a recall of any class.
- 1 other device also cites its predicate K072018.
How does its category compare?
All JGS devicesJGS Electrode, Ion Specific, Sodium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · JGS
3in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · JGS
347in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JGS
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JGS
64in 2025
MAUDE reports naming product code JGS, 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 | 0 | — | 7 | 33 |
| 2008 | 2 | — | 1 | 3 |
| 2009 | 2 | — | 0 | 57 |
| 2010 | 1 | — | 1 | 361 |
| 2011 | 3 | 191 | 1 | 912 |
| 2012 | 1 | — | 2 | 412 |
| 2013 | 2 | — | 5 | 510 |
| 2014 | 1 | — | 0 | 251 |
| 2015 | 1 | — | 1 | 158 |
| 2016 | 4 | 198 | 0 | 84 |
| 2017 | 1 | — | 0 | 292 |
| 2018 | 3 | 180 | 0 | 158 |
| 2019 | 3 | 58 | 5 | 105 |
| 2020 | 2 | — | 1 | 89 |
| 2021 | 0 | — | 1 | 91 |
| 2022 | 1 | — | 0 | 60 |
| 2023 | 3 | 347 | 4 | 98 |
| 2024 | 0 | — | 0 | 96 |
| 2025 | 0 | — | 0 | 64 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The BS-800M/ABS800/BA-800M Chemistry Analyzer is designed for clinical chemistry laboratory use, making direct quantitative measurements of Na+(sodium), K+ (potassium), Cl- (chloride) in serum, plasma and urine samples, and Urea Nitrogen in serum samples. Additionally, other various chemistry tests may be adaptable to the analyzer depending on the reagent used to induce a photometric reaction. The BS-800M/ABS800/BA-800M ISE Kit is for the in vitro…
Read the full statement (161 words)
The BS-800M/ABS800/BA-800M Chemistry Analyzer is designed for clinical chemistry laboratory use, making direct quantitative measurements of Na+(sodium), K+ (potassium), Cl- (chloride) in serum, plasma and urine samples, and Urea Nitrogen in serum samples. Additionally, other various chemistry tests may be adaptable to the analyzer depending on the reagent used to induce a photometric reaction.
The BS-800M/ABS800/BA-800M ISE Kit is for the in vitro quantitative determination of Sodium (Na+), Potassium (K+), and Chloride (Cl-) concentrations in serum, plasma and urine samples on the The BS-800M/ABS800/BA-800M Chemistry Analyzer.
Sodium measurements monitor electrolyte balance and in the diagnosis and treatment of diseases involving electrolyte imbalance.
Potassium measurements monitor electrolyte balance and in the diagnosis and treatment of disease conditions characterized by, low or high blood potassium levels.
Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders.
Urea Nitrogen (BUN) measurements are used to aid in the determination of liver and kidney function and other diseases associated with protein catabolism.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160370 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160370: BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 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/K160370
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