510(k) · Cleared
ClearedOmnis Health Embrace Glucose Control Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bionostics, Inc. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Nov 6, 2009 as substantially equivalent to K090043 (Apex BioTechnology Corp., 2009) after a 129-day review. Its family tree reaches back 1 generation to 2009. 1 later device descends from it.
- Decided
- Nov 6, 2009
- Review
- 129 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K090043 (2009). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK090043 Autosure Voice Blood Glucose Monitoring System, Model AS90011F9Apex BioTechnology Corp. · 2009
- This deviceK091914 Omnis Health Embrace Glucose Control SolutionBionostics, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK133197 Fdi Level I and Level II Glucose Controls for the Embrace NO CodeFujirebio Diagnostics,Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K133197Fdi Level I and Level II Glucose Controls for the Embrace NO CodeFujirebio Diagnostics,Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K090043 | Autosure Voice Blood Glucose Monitoring System, Model AS90011F9 | Apex BioTechnology Corp. | 2009 | — |
| 0 (this device) | K091914 | Omnis Health Embrace Glucose Control Solution | Bionostics, Inc. | 2009 | — |
| +1 | K133197 | Fdi Level I and Level II Glucose Controls for the Embrace NO Code | Fujirebio Diagnostics,Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 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 |
|---|---|---|---|
| * | K090043 | Autosure Voice Blood Glucose Monitoring System, Model AS90011F9Summary page 1…Product Li Low Solution Li Low Control L2 High Solution L2 High Control 510(k) [ K090043 K090043 Net Fill 4 mL 2.5 mL… | 2009 |
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 |
|---|---|---|---|
| K133197 | Fdi Level I and Level II Glucose Controls for the Embrace NO Code | 2014 | 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?
- Its one ancestor has no recall.
- Of its descendants, K133197 (Fujirebio Diagnostics,Inc., 2014) has gone furthest, with 0 descendants of its own.
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. 2009, 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?
OMNIS Health Embrace Glucose Control Solution is intended to assess the performance of OMNIS Health Embrace Blood Glucose test systems. OMNIS Health Embrace Glucose Control Solution is 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/K091914 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091914: Omnis Health Embrace Glucose Control Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091914
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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