510(k) · Cleared
Recalled · 2008Modification to Liquid Glucose (Hexokinase) Reagent Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pointe Scientific, Inc., · CFR Hexokinase, Glucose
Cleared on Nov 20, 2000 after a 123-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it. It has been recalled 14 times.
- Decided
- Nov 20, 2000
- Review
- 123 days
- Class
- Class II
- Product code
- CFR
- Recalls
- 14
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK002199 Modification to Liquid Glucose (Hexokinase) Reagent SetPointe Scientific, Inc., · 2000
- Descendant · cites it directly · 3 of its ownK072018 BS-200 Chemistry Analyzer, Mode BS-200Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · Recalled
- Descendant · 2 generations on · 1 of its ownK112377 BS-400 Chemistry Analyzer, CLC 720 Chemistry AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2012
- Descendant · 2 generations on · 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 · 3 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 4 of 4 · See all- K072018BS-200 Chemistry Analyzer, Mode BS-200Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · cites it directly3descendants
- K112377BS-400 Chemistry Analyzer, CLC 720 Chemistry AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2012 · 2 generations on1descendant
- K160370BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2016 · 2 generations on0descendants
- K140690BS-480 Chemistry Analyzer, BS-490 Chemistry Analyzer, CLC720I Chemistry AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002199 | Modification to Liquid Glucose (Hexokinase) Reagent Set | Pointe Scientific, Inc., | 2000 | — |
| +1 | K072018 | BS-200 Chemistry Analyzer, Mode BS-200 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | 1 |
| +2 | K112377 | BS-400 Chemistry Analyzer, CLC 720 Chemistry Analyzer | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2012 | — |
| +2 | K160370 | BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016 | 2 |
| +3 | K140690 | BS-480 Chemistry Analyzer, BS-490 Chemistry Analyzer, CLC720I Chemistry Analyzer | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072018 | BS-200 Chemistry Analyzer, Mode BS-200 | 2008 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 10, 2008 | Not classified | Z-0221-2009 | Process control | The inability of the product to maintain stated performance specifications through the stated shelf life. |
| Sep 10, 2008 | Not classified | Z-0223-2009 | Process control | The inability of the product to maintain stated performance specifications through the stated shelf life. |
| Sep 10, 2008 | Not classified | Z-0222-2009 | Process control | The inability of the product to maintain stated performance specifications through the stated shelf life. |
| Sep 10, 2008 | Not classified | Z-0219-2009 | Process control | The inability of the product to maintain stated performance specifications through the stated shelf life. |
| Sep 10, 2008 | Not classified | Z-0220-2009 | Process control | The inability of the product to maintain stated performance specifications through the stated shelf life. |
| Sep 10, 2008 | Not classified | Z-0224-2009 | Process control | The inability of the product to maintain stated performance specifications through the stated shelf life. |
| Jun 7, 2006 | Not classified | Z-1329-06 | Other | Product does not meet performance specifications through its labeled expiration period. |
| Jun 7, 2006 | Not classified | Z-1328-06 | Other | Product does not meet performance specifications through its labeled expiration period. |
| Jun 7, 2006 | Not classified | Z-1327-06 | Other | Product does not meet performance specifications through its labeled expiration period. |
| Jun 7, 2006 | Not classified | Z-1326-06 | Other | Product does not meet performance specifications through its labeled expiration period. |
| Jun 7, 2006 | Not classified | Z-1330-06 | Other | Product does not meet performance specifications through its labeled expiration period. |
| Jun 7, 2006 | Not classified | Z-1333-06 | Other | Product does not meet performance specifications through its labeled expiration period. |
| Jun 7, 2006 | Not classified | Z-1332-06 | Other | Product does not meet performance specifications through its labeled expiration period. |
| Jun 7, 2006 | Not classified | Z-1331-06 | Other | Product does not meet performance specifications through its labeled expiration period. |
The 5 latest of 14 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K072018 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2008) has gone furthest, with 3 descendants of its own.
How does its category compare?
All CFR devicesCFR Hexokinase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K002199 · printed Nov 3, 2026
Cite this page
510(k) Report. “K002199: Modification to Liquid Glucose (Hexokinase) Reagent Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K002199
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026