510(k) · Cleared
Recalled · Class II · 2021Remel Bile Esculin Azide Agar W/6 MCG/ML Vancomycin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Remel, L.P. · JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Cleared on Aug 28, 1997 after a 64-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 19 later devices descend from it. It has been recalled once.
- Decided
- Aug 28, 1997
- Review
- 64 days
- Class
- Class II
- Product code
- JSO
- Recalls
- 1
- Predicates
- 0
19 later devices descend from it, 6 citing it directly.
- This deviceK972359 Remel Bile Esculin Azide Agar W/6 MCG/ML VancomycinRemel, L.P. · 1997
- Descendant · cites it directly · 9 of its ownK061686 Idi-Vanr AssayGeneohm Sciences Canada, Inc. · 2006
- Descendant · cites it directly · 8 of its ownK092953 Xpert VanA AssayCepheid · 2009
- Descendant · 2 generations on · 6 of its ownK152614 Xpert Carba-RCepheid · 2016
- Descendant · 3 generations on · 3 of its ownK160901 Xpert Carba-RCepheid · 2016
- Descendant · cites it directly · 3 of its ownK122187 Vreselect Culture MediumBio-Rad · 2012
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K061686Idi-Vanr AssayGeneohm Sciences Canada, Inc. · 2006 · cites it directly9descendants
- K092953Xpert VanA AssayCepheid · 2009 · cites it directly8descendants
- K152614Xpert Carba-RCepheid · 2016 · 2 generations on6descendants
- K160901Xpert Carba-RCepheid · 2016 · 3 generations on3descendants
- K122187Vreselect Culture MediumBio-Rad · 2012 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972359 | Remel Bile Esculin Azide Agar W/6 MCG/ML Vancomycin | Remel, L.P. | 1997 | — |
| +1 | K061686 | Idi-Vanr Assay | Geneohm Sciences Canada, Inc. | 2006 | — |
| +1 | K092953 | Xpert VanA Assay | Cepheid | 2009 | — |
| +2 | K152614 | Xpert Carba-R | Cepheid | 2016 | — |
| +3 | K160901 | Xpert Carba-R | Cepheid | 2016 | — |
| +1 | K122187 | Vreselect Culture Medium | Bio-Rad | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (19)
See all 196 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 22, 2021 | Class II | Z-1561-2021 | Mixed-up of materials/components | The media allows growth of E. faecalis ATCC 29212 with blackening of the media. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K061686 (Geneohm Sciences Canada, Inc., 2006) has gone furthest, with 9 descendants of its own.
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.
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?
REMEL's Bile Esculin Azide Agar w/ 6 pg/ml Vancomycin is a plated medium recommended for use in qualitative procedures as a selective and differential medium for the primary isolation of vancomycin resistant enterococci from surveillance cultures. This product is not intended for use as method of antimicrobial susceptibility testing. Confirmation of vancomycin resistance by an approved method is recommended as some organisms on initial isolation may overcome the inhibitory effects of the medium.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972359 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972359: Remel Bile Esculin Azide Agar W/6 MCG/ML Vancomycin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972359
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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