510(k) · Cleared
ClearedRemel Spectra Vre
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermo Fisher Scientific · JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Cleared on Jul 15, 2010 after a 304-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Jul 15, 2010
- Review
- 304 days
- Class
- Class II
- Product code
- JSO
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK092819 Remel Spectra VreThermo Fisher Scientific · 2010
- Descendant · cites it directly · 3 of its ownK122187 Vreselect Culture MediumBio-Rad · 2012
- Descendant · 2 generations on · 1 of its ownK160512 HardyCHROM ESBLHardy Diagnostics · 2016
- Descendant · 2 generations on · 0 of its ownK190553 HardyCHROM CREHardy Diagnostics · 2019 · Recalled
- Descendant · 3 generations on · 0 of its ownK162620 Remel Spectra ESBLRemel, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK103684 Vreselect Culture MediumBio-Rad · 2011
Most influential descendants
Showing 5 of 5 · See all- K122187Vreselect Culture MediumBio-Rad · 2012 · cites it directly3descendants
- K160512HardyCHROM ESBLHardy Diagnostics · 2016 · 2 generations on1descendant
- K190553HardyCHROM CREHardy Diagnostics · 2019 · 2 generations on0descendants
- K162620Remel Spectra ESBLRemel, Inc. · 2017 · 3 generations on0descendants
- K103684Vreselect Culture MediumBio-Rad · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K092819 | Remel Spectra Vre | Thermo Fisher Scientific | 2010 | — |
| +1 | K122187 | Vreselect Culture Medium | Bio-Rad | 2012 | — |
| +2 | K160512 | HardyCHROM ESBL | Hardy Diagnostics | 2016 | — |
| +2 | K190553 | HardyCHROM CRE | Hardy Diagnostics | 2019 | 1 |
| +3 | K162620 | Remel Spectra ESBL | Remel, Inc. | 2017 | — |
| +1 | K103684 | Vreselect Culture Medium | Bio-Rad | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | — | Remel Bile Esculin Azide Agar with 6 pg/ml Vancomycin Named without a submission number |
What descends from it? (5)
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?
- Of its descendants, K122187 (Bio-Rad, 2012) has gone furthest, with 3 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. 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?
Remel Spectra TM VRE is a selective and differential chromogenic medium, containing 6 pg/mi of vancomycin, intended for use in the qualitative detection of gastrointestinal colonization with vancomycin-resistant Enterococcus faecium and Enterococcus faecalis (VIRE) to aid in the prevention and control of VRE in healthcare settings. The test is performed with rectal swab and fecal specimens from patients to screen for VRE colonization. Spectra TM VRE is…
Read the full statement (103 words)
Remel Spectra TM VRE is a selective and differential chromogenic medium, containing 6 pg/mi of vancomycin, intended for use in the qualitative detection of gastrointestinal colonization with vancomycin-resistant Enterococcus faecium and Enterococcus faecalis (VIRE) to aid in the prevention and control of VRE in healthcare settings. The test is performed with rectal swab and fecal specimens from patients to screen for VRE colonization. Spectra TM VRE is not intended to diagnose VRE infection or to guide* or monitor treatment for infections. Subculture to non-selective media (e.g. Tryptic 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/K092819 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092819: Remel Spectra Vre.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092819
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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