510(k) · Cleared
ClearedRemel Spectra ESBL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Remel, Inc. · JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Cleared on May 1, 2017 as substantially equivalent to K160512 (Hardy Diagnostics, 2016) after a 223-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- May 1, 2017
- Review
- 223 days
- Class
- Class II
- Product code
- JSO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K972359 (1997). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K972359 | Remel Bile Esculin Azide Agar W/6 MCG/ML Vancomycin | Remel, L.P. | 1997 | 1 |
| −2 | K122187 | Vreselect Culture Medium | Bio-Rad | 2012 | — |
| −1 | K160512 | HardyCHROM ESBL | Hardy Diagnostics | 2016 | — |
| 0 (this device) | K162620 | Remel Spectra ESBL | Remel, Inc. | 2017 | — |
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? (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 |
|---|---|---|---|
| * | K160512 | HardyCHROM ESBL Cleared while this submission was under review Summary page 5…*Adjusted as required to meet performance standards. Device Comparison: Substantial Equivalence Information: Predicate K number: K160512, HardyCHROM™ ESBL Characteristic Remel Spectra™ ESBL… | 2016 |
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?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 4 ancestors has 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. 2017, 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 ESBL is a selective and differential growth medium for use in primary isolation and presumptive identification of Extended Spectrum β Lactamase (ESBL)-producing Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca and Proteus mirabilis to aid in prevention and control of these bacteria in a healthcare setting. Testing may be performed from either perirectal swabs or fresh stool specimens. Remel Spectra ESBL is not intended to…
Read the full statement (137 words)
Remel Spectra ESBL is a selective and differential growth medium for use in primary isolation and presumptive identification of Extended Spectrum β Lactamase (ESBL)-producing Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca and Proteus mirabilis to aid in prevention and control of these bacteria in a healthcare setting. Testing may be performed from either perirectal swabs or fresh stool specimens. Remel Spectra ESBL is not intended to diagnose ESBL infection, or to guide or monitor treatment.
Do not report Spectra ESBL positive screening results. Subculture of presumptively positive colonies to non-selective medium (e.g., Tryptic Soy Agar with 5% sheep blood) is required for organism identification, confirmatory testing for ESBL, susceptibility testing and epidemiological typing.
A lack of growth or the absence of pink, blue-turquoise-green or tan colonies on Spectra ESBL does not preclude the presence of ESBL producing organisms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162620 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162620: Remel Spectra ESBL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162620
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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