510(k) · Cleared
ClearedApolowako HBA1C, Glucose and Analyzer, Models 993-24601, 991-24401 and 993-25201
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wako Chemicals USA, Inc. · CFR Hexokinase, Glucose
Cleared on Jul 17, 2008 as substantially equivalent to K904082 (Cholestech Corp., 1990) and 1 other predicate after a 182-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Jul 17, 2008
- Review
- 182 days
- Class
- Class II
- Product code
- CFR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K904082 (1990). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK904082 Cholestech Lipid Monitoring System, Glucose TestCholestech Corp. · 1990 · Recalled
- This deviceK080123 Apolowako HBA1C, Glucose and Analyzer, Models 993-24601, 991-24401…Wako Chemicals USA, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K904082 | Cholestech Lipid Monitoring System, Glucose Test | Cholestech Corp. | 1990 | 1 |
| 0 (this device) | K080123 | Apolowako HBA1C, Glucose and Analyzer, Models 993-24601, 991-24401 and 993-25201 | Wako Chemicals USA, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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? (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 |
|---|---|---|---|
| * | K904082 | Cholestech Lipid Monitoring System, Glucose TestSummary page 1…dentification of the legally marketed predicate device CHOLESTECH LDX and CHOLESTECH GDX, Cholestech Corporation, Hayward, CA cleared under K904082 (LDX), K904082 (Glucose) and K011933 (GDX). 807.92 (a)(4): Device Description The APOLOWAKO analyzer is a f… | 1990 |
| * | K011933 | Glycosal II Hba 1C TestSummary page 1…ice CHOLESTECH LDX and CHOLESTECH GDX, Cholestech Corporation, Hayward, CA cleared under K904082 (LDX), K904082 (Glucose) and K011933 (GDX). 807.92 (a)(4): Device Description The APOLOWAKO analyzer is a fully-integrated POC test system that can per… | 2001 |
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?
- 1 of the 2 ancestors has a recall of any class.
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?
HbAlc- Measurement of % HbAlc is used to monitor long-term glucose control in individuals with diabetes mellitus.
Glucose- Measurement of glucose is used in the diagnosis and treatment of carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia and pancreatic islet cell carcinoma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080123 · printed Nov 4, 2026
Cite this page
510(k) Report. “K080123: Apolowako HBA1C, Glucose and Analyzer, Models 993-24601, 991-24401 and 993-25201.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K080123
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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