510(k) · Cleared
ClearedTosoh Automated Glycohemoglobin Analyzer HLC-723G8
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tosoh Bioscience, Inc. · PDJ Hemoglobin A1c Test System
Cleared on Aug 5, 2021 after a 486-day review. The summary cites 2 numbers, none of which could be confirmed as its predicate (see the table below). 1 later device descends from it.
- Decided
- Aug 5, 2021
- Review
- 486 days
- Class
- Class II
- Product code
- PDJ
- Recalls
- None
- Predicates
- 2
1 later device descends from it, 1 citing it directly.
- This deviceK200904 Tosoh Automated Glycohemoglobin Analyzer HLC-723G8Tosoh Bioscience, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK250073 Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01Tosoh Bioscience, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K250073Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01Tosoh Bioscience, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K200904 | Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 | Tosoh Bioscience, Inc. | 2021 | — |
| +1 | K250073 | Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 | Tosoh Bioscience, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 PDJ? 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 PDJ device
- #1 K252749 Medconn 8K Glycated Hemoglobin Test Systemscore 11.5 · 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K122472 | FDA’s K122472 is Variant II Turbo HBA1C Kit-2.0 Variant II Turbo Hemoglobin Testing System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2012 |
| Kept off the family tree | K142448 | FDA’s K142448 is VARIANT II TURBO HbA1c Kit - 2.0 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2015 |
| † | K112015 | Premier HB9210 HBA1C Analyzer | 2011 |
| † | K891235 | Primus Model CLC 330 | 1989 |
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 |
|---|---|---|---|
| K250073 | Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 | 2025 | 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?
- Of its descendants, K250073 (Tosoh Bioscience, Inc., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PDJ devicesPDJ Hemoglobin A1c Test System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · PDJ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PDJ
203in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PDJ
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PDJ
42in 2025
MAUDE reports naming product code PDJ, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 9 |
| 2014 | 2 | — | 0 | 10 |
| 2015 | 4 | 234 | 0 | 2 |
| 2016 | 2 | — | 1 | 0 |
| 2017 | 3 | 173 | 0 | 1 |
| 2018 | 5 | 203 | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 5 |
| 2021 | 2 | — | 0 | 6 |
| 2022 | 0 | — | 1 | 19 |
| 2023 | 0 | — | 0 | 16 |
| 2024 | 1 | — | 0 | 47 |
| 2025 | 2 | — | 0 | 42 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for in vitro diagnostic use for the measurement of % hemoglobin A1c (HbA1c) (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in venous whole blood specimens using ion-exchange high-performance liquid chromatography (HPLC). This test is to be used as an aid in diagnosis of diabetes and identifying patients who may be at risk for developing diabetes, and for monitoring of long-term blood glucose control in individuals with diabetes mellitus.
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/K200904 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200904: Tosoh Automated Glycohemoglobin Analyzer HLC-723G8.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200904
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