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 Oct 21, 2011 as substantially equivalent to K092819 (Thermo Fisher Scientific, 2010) and 1 other predicate after a 308-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Oct 21, 2011
- Review
- 308 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. No later device cites it as a predicate yet.
- Root · 1 generation backK972359 Remel Bile Esculin Azide Agar W/6 MCG/ML VancomycinRemel, L.P. · 1997 · Recalled
- This deviceK103684 Vreselect Culture MediumBio-Rad · 2011
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) | K103684 | Vreselect Culture Medium | Bio-Rad | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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…Substantially Equivalent Device VRESeeCI TM is substantially equivalent to the Thermo Fisher Scientific (formerly Remel) Spectra VRE Chromogenic Media (reference 510(k) K092819) and the Thermo Fisher Bile Esculin Azide Agar with 6pg/mL vancomycin (reference 510(k) K972359). The predicate device Package In… | 2010 |
| * | K972359 | Remel Bile Esculin Azide Agar W/6 MCG/ML VancomycinSummary page 1…ientific (formerly Remel) Spectra VRE Chromogenic Media (reference 510(k) K092819) and the Thermo Fisher Bile Esculin Azide Agar with 6pg/mL vancomycin (reference 510(k) K972359). The predicate device Package Inserts are included for reference (see Appendix 11). Manufacturer: Thermo Fisher Scientific… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K092819.
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. 2011, 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 jig/mL of vancomycin, for the qualitative detection of gastrointestinal colonization of vancomycin-resistant Enterococcusfaecium (VREfmn) and vancomycin-resistant Enterococcusfaecalis(VREfs) and to aid in the prevention and control of vancomycin-resistant Enterococcus (VRE) in healtheare settings. The test is performed on rectal swabs from patients to be screened for VRE…
Read the full statement (105 words)
VRESelect TM is a selective and differential chromogenic medium, containing 8 jig/mL of
vancomycin, for the qualitative detection of gastrointestinal colonization of vancomycin-resistant
Enterococcusfaecium (VREfmn) and vancomycin-resistant Enterococcusfaecalis(VREfs) and to
aid in the prevention and control of vancomycin-resistant Enterococcus (VRE) in healtheare
settings. The test is performed on rectal swabs from patients to be screened for VRE
colonization. VRESelect TM 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 need for susceptibility
testing and epidemiological typing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103684 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103684: Vreselect Culture Medium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103684
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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