510(k) · Cleared
ClearedHardyCHROM ESBL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hardy Diagnostics · JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Cleared on Nov 15, 2016 as substantially equivalent to K122187 (Bio-Rad, 2012) after a 265-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.
- Decided
- Nov 15, 2016
- Review
- 265 days
- Class
- Class II
- Product code
- JSO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K972359 (1997). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK972359 Remel Bile Esculin Azide Agar W/6 MCG/ML VancomycinRemel, L.P. · 1997 · Recalled
- 1 generation backK122187 Vreselect Culture MediumBio-Rad · 2012
- This deviceK160512 HardyCHROM ESBLHardy Diagnostics · 2016
- Descendant · cites it directly · 0 of its ownK162620 Remel Spectra ESBLRemel, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K162620Remel Spectra ESBLRemel, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K972359 | Remel Bile Esculin Azide Agar W/6 MCG/ML Vancomycin | Remel, L.P. | 1997 | 1 |
| −1 | K122187 | Vreselect Culture Medium | Bio-Rad | 2012 | — |
| 0 (this device) | K160512 | HardyCHROM ESBL | Hardy Diagnostics | 2016 | — |
| +1 | 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 |
|---|---|---|
| 2017 | 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 |
|---|---|---|---|
| * | K122187 | Vreselect Culture MediumSummary page 4…yCHROM™ ESBL Classification Name: Culture medium for anti-microbial susceptibility tests Regulatory Class: II Product Code: JSO III. PREDICATE DEVICE Bio Rad VRESelect, K122187 IV. DEVICE DESCRIPTION According to Centers for Disease Control and Prevention (CDC), Extended Spectrum Beta Lactamases (ESBLs)… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162620 | Remel Spectra ESBL | 2017 | 0 |
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 19 years and passes through 3 companies; a new generation was cleared every 15.2 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K162620 (Remel, Inc., 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K122187.
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. 2016, 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?
HardyCHROM ESBL is a selective and differential chromogenic medium which is intended for the qualitative and presumptive detection from stool specimens of: 1) Enterobacteriaceae that are potentially non-susceptible to ceftazidime and cefpodoxime; and 2) Extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli, Klebsiella pneumoniae and Klebsiella oxytoca. The test is performed on stool specimens from patients at risk of harboring…
Read the full statement (168 words)
HardyCHROM ESBL is a selective and differential chromogenic medium which is intended for the qualitative and
presumptive detection from stool specimens of: 1) Enterobacteriaceae that are potentially non-susceptible to ceftazidime
and cefpodoxime; and 2) Extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli, Klebsiella pneumoniae
and Klebsiella oxytoca.
The test is performed on stool specimens from patients at risk of harboring Enterobacteriaceae that are non-susceptible to
3rd generation cephalosporins or ESBL-producing E. coli, K. pneumoniae and K. oxytoca, and is intended as an aid in the
detection, identification of colonization and control of these bacteria in a healthcare setting. HardyCHROM ESBL is not
intended to diagnose infection or to guide or monitor treatment for infections. Results can be interpreted after incubation
for 18-24 hours. Subculture to non-selective medium is required for confirming identification, susceptibility testing and
epidemiological typing.
A lack of growth or the absence of pink, blue or yellow/gold colonies on HardyCHROM ESBL does not preclude the
presence of Enterobacteriaceae that are non-susceptible to 3rd generation cephalosporins or ESBL producing organisms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160512 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160512: HardyCHROM ESBL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160512
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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