510(k) · Cleared
ClearedVreselect Culture Medium
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad · JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Cleared on Nov 6, 2012 as substantially equivalent to K092819 (Thermo Fisher Scientific, 2010) and 1 other predicate after a 105-day review. Its family tree reaches back 1 generation to 1997. 3 later devices descend from it.
- Decided
- Nov 6, 2012
- Review
- 105 days
- Class
- Class II
- Product code
- JSO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K972359 (1997). 2 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK972359 Remel Bile Esculin Azide Agar W/6 MCG/ML VancomycinRemel, L.P. · 1997 · Recalled
- This deviceK122187 Vreselect Culture MediumBio-Rad · 2012
- Descendant · cites it directly · 1 of its ownK160512 HardyCHROM ESBLHardy Diagnostics · 2016
- Descendant · cites it directly · 0 of its ownK190553 HardyCHROM CREHardy Diagnostics · 2019 · Recalled
- Descendant · 2 generations on · 0 of its ownK162620 Remel Spectra ESBLRemel, Inc. · 2017
Most influential descendants
Showing 3 of 3 · See allView 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) | K122187 | Vreselect Culture Medium | Bio-Rad | 2012 | — |
| +1 | K160512 | HardyCHROM ESBL | Hardy Diagnostics | 2016 | — |
| +1 | K190553 | HardyCHROM CRE | Hardy Diagnostics | 2019 | 1 |
| +2 | K162620 | Remel Spectra ESBL | Remel, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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? (2)
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 |
|---|---|---|---|
| * | K092819 | Remel Spectra VreSummary page 1…ubstantially Equivalent Device VRESelect TM is substantially equivalent to the Thermo Fisher Scientific (formerly Remel) Spectra VRE Chromogenic Media (reference 5 10(k) K0928 19) and the Thermo Fisher Bile Esculin Azide Agar with 6ptg/mL vancomycin (reference 5 10(k) K972359). The predicate device Package… | 2010 |
| * | K972359 | Remel Bile Esculin Azide Agar W/6 MCG/ML VancomycinSummary page 1…ific (formerly Remel) Spectra VRE Chromogenic Media (reference 5 10(k) K0928 19) and the Thermo Fisher Bile Esculin Azide Agar with 6ptg/mL vancomycin (reference 5 10(k) K972359). The predicate device Package Inserts are included for reference (see Appendix 11). Manufacturer: Thermo Fisher Scientific (f… | 1997 |
What descends from it? (3)
2 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)
No FDA recall names this device.
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. 2012, 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?
VRESelect TM is a selective and differential chromogenic medium, containing 8 pg/mL of vancomycin, for the qualitative detection of gastrointestinal colonization of vancomycin-resistant Enterococcus faecium (VREfm) and vancomycin-resistant Enterococcus faecalis (VREfs) and to aid in the prevention and control of vancomycin-resistant Enterococcus (VRE) in healthcare settings. The test is performed on rectal swabs or fecal specimens from patients to be…
Read the full statement (110 words)
VRESelect TM is a selective and differential chromogenic medium, containing 8 pg/mL of vancomycin, for the qualitative detection of gastrointestinal colonization of vancomycin-resistant Enterococcus faecium (VREfm) and vancomycin-resistant Enterococcus faecalis (VREfs) and to aid in the prevention and control of vancomycin-resistant Enterococcus (VRE) in healthcare settings. The test is performed on rectal swabs or fecal specimens from patients to be screened for VRE colonization. VRESelectTh is not intended to diagnose VRE infection nor to guide or monitor treatment of infection. Results can be interpreted after 24 to 28 hours incubation. Subculture to non-selective media (e.g., trypticase soy agar with 5% sheep blood) is needed for susceptibility testing and epidemniological typing.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K122187 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122187: Vreselect Culture Medium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122187
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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