510(k) · Cleared
Recalled · Class II · 2022Chromid Vre Agar, Model: Ref 43 851
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
bioMerieux, Inc. · JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Cleared on Mar 2, 2010 as substantially equivalent to K972359 (Remel, L.P., 1997) after a 326-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it. It has been recalled once.
- Decided
- Mar 2, 2010
- Review
- 326 days
- Class
- Class II
- Product code
- JSO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K972359 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK972359 Remel Bile Esculin Azide Agar W/6 MCG/ML VancomycinRemel, L.P. · 1997 · Recalled
- This deviceK091025 Chromid Vre Agar, Model: Ref 43 851bioMerieux, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK181092 CHROMID CARBA agar (CARB)Biomerieux S.A. · 2018 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K181092CHROMID CARBA agar (CARB)Biomerieux S.A. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972359 | Remel Bile Esculin Azide Agar W/6 MCG/ML Vancomycin | Remel, L.P. | 1997 | 1 |
| 0 (this device) | K091025 | Chromid Vre Agar, Model: Ref 43 851 | bioMerieux, Inc. | 2010 | — |
| +1 | K181092 | CHROMID CARBA agar (CARB) | Biomerieux S.A. | 2018 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 JSO? 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 |
|---|---|---|---|
| * | K972359 | Remel Bile Esculin Azide Agar W/6 MCG/ML VancomycinSummary page 1…e media C. Predicate Device: Remel Bile Esculin Azide Agar wI6pgtml Vancomycin, K972359 D. 510(k) Summary: Intended Use: chromll) m VRE agar is a selective and differential chromogenic medium containing… | 1997 |
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 |
|---|---|---|---|
| K181092 | CHROMID CARBA agar (CARB) | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 9, 2022 | Class II | Z-0803-2023 | Storage | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All JSO devicesJSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · JSO
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · JSO
262in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JSO
15in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JSO
513in 2025
MAUDE reports naming product code JSO, 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 | — | 2 | 0 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 1 | — | 4 | 0 |
| 2010 | 5 | 326 | 0 | 1 |
| 2011 | 2 | — | 3 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 32 |
| 2016 | 3 | 262 | 0 | 17 |
| 2017 | 2 | — | 2 | 43 |
| 2018 | 1 | — | 0 | 14 |
| 2019 | 1 | — | 0 | 9 |
| 2020 | 0 | — | 1 | 7 |
| 2021 | 0 | — | 0 | 27 |
| 2022 | 0 | — | 15 | 8 |
| 2023 | 0 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 513 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
chromllorM VRE agar is a selective and differential chromogenic medium containing 8 pg/mL of
vancomycin, for the qualitative detection of Enterococcus faecium and B. faecalis showing
acquired vancomycin resistance (VRE) in stool specimens. chromlD TM VRE agar can be used
as an aid to identify, prevent and control VRE colonization in healthcare settings. chromlD TM VRE
agar is not intended to diagnose VRE infection nor to guide or monitor treatment for infections.
Subculture to non-selective media (e.g. trypticase soy agar with 5% sheep blood) is needed for
further identification, susceptibility testing and epidemiological typing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091025 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091025: Chromid Vre Agar, Model: Ref 43 851.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091025
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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