510(k) · Cleared
ClearedFdi Level I and Level II Glucose Controls for the Embrace NO Code
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujirebio Diagnostics,Inc. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Jan 17, 2014 as substantially equivalent to K091914 (Bionostics, Inc., 2009) after a 92-day review. Its family tree reaches back 2 generations to 2009.
- Decided
- Jan 17, 2014
- Review
- 92 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K090043 (2009). No later device cites it as a predicate yet.
- Root · 2 generations backK090043 Autosure Voice Blood Glucose Monitoring System, Model AS90011F9Apex BioTechnology Corp. · 2009
- 1 generation backK091914 Omnis Health Embrace Glucose Control SolutionBionostics, Inc. · 2009
- This deviceK133197 Fdi Level I and Level II Glucose Controls for the Embrace NO CodeFujirebio Diagnostics,Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K090043 | Autosure Voice Blood Glucose Monitoring System, Model AS90011F9 | Apex BioTechnology Corp. | 2009 | — |
| −1 | K091914 | Omnis Health Embrace Glucose Control Solution | Bionostics, Inc. | 2009 | — |
| 0 (this device) | K133197 | Fdi Level I and Level II Glucose Controls for the Embrace NO Code | Fujirebio Diagnostics,Inc. | 2014 | — |
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 JJX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K091914 | Omnis Health Embrace Glucose Control SolutionSummary page 1…Solutions Manufacturer: Bionostics 510(k) No.: k091 914 Device Description: The FDI Glucose Controls for the Embrace No Code consist of a viscos… | 2009 |
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?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All JJX devicesJJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · JJX
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJX
31in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJX
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJX
22in 2025
MAUDE reports naming product code JJX, 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 | 6 | 53 | 3 | 2 |
| 2008 | 8 | 52 | 3 | 0 |
| 2009 | 17 | 80 | 0 | 1 |
| 2010 | 24 | 80 | 3 | 6 |
| 2011 | 19 | 62 | 2 | 62 |
| 2012 | 15 | 40 | 0 | 32 |
| 2013 | 19 | 37 | 0 | 51 |
| 2014 | 22 | 30 | 1 | 48 |
| 2015 | 11 | 65 | 1 | 67 |
| 2016 | 6 | 31 | 2 | 37 |
| 2017 | 2 | — | 0 | 19 |
| 2018 | 0 | — | 2 | 35 |
| 2019 | 0 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 77 |
| 2021 | 0 | — | 1 | 43 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The FDI Glucose Controls are intended for use with Embrace No Code blood glucose meter and test strips. The controls are used to check that the meter and test strips are working together properly.
The FDI Glucose Controls for the Embrace No Code are intended for use by healthcare professionals and people with diabetes mellitus at home.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133197 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133197: Fdi Level I and Level II Glucose Controls for the Embrace NO Code.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133197
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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