510(k) · Cleared
Recalled · Class II · 2022CHROMID CARBA agar (CARB)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomerieux S.A. · JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Cleared on Jul 6, 2018 as substantially equivalent to K091025 (bioMerieux, Inc., 2010) after a 72-day review. Its family tree reaches back 2 generations to 1997. It has been recalled once.
- Decided
- Jul 6, 2018
- Review
- 72 days
- Class
- Class II
- Product code
- JSO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K972359 (1997). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K091025 | Chromid Vre Agar, Model: Ref 43 851Summary page 4…obial Susceptibility Test, Excluding Mueller Hinton Agar Common Name: CHROMID® CARBA agar (CARB) C. Predicate Device: CHROMID® VRE agar (K091025) D. 510(k) Summary: Intended Use: CHROMID® CARBA agar is a selective and differential chromogenic medium that is intended for t… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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-0839-2023 | 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?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 12.5 years on median.
- 2 of the 2 ancestors have a recall of any class.
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. 2018, 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?
CHROMID® CARBA agar is a selective and differential chromogenic medium that is intended for the qualitative detection and presumptive identification of carbapenemase-producing Escherichia coli and Klebsiella pneumoniae in rectal swab specimens from patients at risk of colonization. CHROMID® CARBA agar is intended as an aid in the detection, identification of colonization and control of these bacteria in a healthcare setting. Rectal swabs are inoculated…
Read the full statement (173 words)
CHROMID® CARBA agar is a selective and differential chromogenic medium that is intended for the qualitative detection and presumptive identification of carbapenemase-producing Escherichia coli and Klebsiella pneumoniae in rectal swab specimens from patients at risk of colonization. CHROMID® CARBA agar is intended as an aid in the detection, identification of colonization and control of these bacteria in a healthcare setting.
Rectal swabs are inoculated directly onto CHROMID® CARBA agar without enrichment and results can be interpreted after incubation for 18-24 hours. Presumptive carbapenemase-producing colonies of E. coli appear pink to burgundy and those of K. pneumoniae appear blue-green or blue-grey.
Other organisms besides carbapenemase-producing E. coli and K. pneumoniae can also grow on CHROMID® CARBA agar with colonies that appear pink to burgundy or blue-green to blue-grey. Sub-culture to non-selective medium is required to confirm organism identity, for antimicrobial susceptibility testing, confirmation of carbapenemase production and epidemiological typing.
A lack of growth or the absence of pink to burgundy or blue-green to blue-grey colonies does not preclude the carriage of carbapenemase producing organisms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181092 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181092: CHROMID CARBA agar (CARB).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181092
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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