510(k) · Cleared
ClearedAdvia 1650 Glucose Hexokinase 11 Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Corp. · CFR Hexokinase, Glucose
Cleared on Nov 20, 2001 as substantially equivalent to K991576 (Bayer Corp., 1999) after a 151-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Nov 20, 2001
- Review
- 151 days
- Class
- Class II
- Product code
- CFR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K991576 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK991576 Additional Assays for the Bayer Advia 1650 Chemistry SystemBayer Corp. · 1999 · Recalled
- This deviceK011963 Advia 1650 Glucose Hexokinase 11 AssayBayer Corp. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991576 | Additional Assays for the Bayer Advia 1650 Chemistry System | Bayer Corp. | 1999 | 3 |
| 0 (this device) | K011963 | Advia 1650 Glucose Hexokinase 11 Assay | Bayer Corp. | 2001 | — |
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? (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 |
|---|---|---|---|
| * | K991576 | Additional Assays for the Bayer Advia 1650 Chemistry SystemSummary page 1…ia and insulin overdose. 2. Predicate Device Product Name Reagent Part# | Calibrator Part# | Predicate Device # ADVIA 1650 Glucose Hexokinase |B01-4129-01 |T03-1291-62 K991576 3. Device / Method Product Name REF Calibrator Part # ADVIA 1650 Glucose Hexokinase II |04903429 |T03-1291-62 A. Imprecision ADVI… | 1999 |
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?
- Its one ancestor has a recall.
- 11 other devices also cite its predicate K991576.
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 | — |
What is it indicated for?
The Glucose Hexokinase II in vitro diagnostic procedure is intended to measure glucose in human serum,
plasma and urine on the Bayer Advia 1650 system. Such measurement is used in the diagnosis and treatment of
carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic
hypoglycemia and insulin overdose.
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/K011963 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011963: Advia 1650 Glucose Hexokinase 11 Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011963
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026