510(k) · Cleared
Recalled · Class II · 2018Mrsaselect - Extended Incubation
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 Jun 13, 2008 as substantially equivalent to K070361 (Bio-Rad, 2007) after a 45-day review. Its family tree reaches back 3 generations to 1986. 3 later devices descend from it. It has been recalled once.
- Decided
- Jun 13, 2008
- Review
- 45 days
- Class
- Class II
- Product code
- JSO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K863821 (1986). 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK863821 Mueller Hinton Agar W/4%Nacl and OxacillinGibco Laboratories Life Technologies, Inc. · 1986 · Recalled
- 2 generations backK042812 Bblchromagar MrsaBecton, Dickinson & CO · 2004
- 1 generation backK070361 MrsaselectBio-Rad · 2007
- This deviceK081212 Mrsaselect - Extended IncubationBio-Rad · 2008
- Descendant · cites it directly · 2 of its ownK100589 Mrsa Select - Skin and Soft Tissue Wound SpecimensBio-Rad · 2010
- Descendant · cites it directly · 0 of its ownK171061 MRSASelect IIBio-Rad · 2017 · Recalled
- Descendant · 2 generations on · 0 of its ownK151688 chromID MRSAbioMerieux, Inc. · 2016
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 |
|---|---|---|---|---|---|
| −3 | K863821 | Mueller Hinton Agar W/4%Nacl and Oxacillin | Gibco Laboratories Life Technologies, Inc. | 1986 | 1 |
| −2 | K042812 | Bblchromagar Mrsa | Becton, Dickinson & CO | 2004 | — |
| −1 | K070361 | Mrsaselect | Bio-Rad | 2007 | — |
| 0 (this device) | K081212 | Mrsaselect - Extended Incubation | Bio-Rad | 2008 | — |
| +1 | K100589 | Mrsa Select - Skin and Soft Tissue Wound Specimens | Bio-Rad | 2010 | — |
| +1 | K171061 | MRSASelect II | Bio-Rad | 2017 | 1 |
| +2 | K151688 | chromID MRSA | bioMerieux, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2016 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K070361 | MrsaselectSummary page 2…t Culture Media 510(k) Submission Substantially Equivalent Device MRSASelect with extended incubation times is substantially equivalent to MRSASelect (reference 510(k) K070361). Manufacturer: Bio-Rad Product: MRSASelect Bio-Rad MRSASelectT M Bio-Rad MRSASelectT M… | 2007 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 8, 2018 | Class II | Z-1742-2019 | Nonconforming Material/Component | Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K100589 (Bio-Rad, 2010) has gone furthest, with 2 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. 2008, 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?
MRSASelect is a selective and differential chromogenic medium for the qualitative detection of nasal colonization of methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA infections in healthcare settings. The test can be performed on anterior nares specimens from patients and healthcare workers to screen for MRSA colonization. MRSASelect is not intended to diagnose MRSA infection nor to guide or monitor treatment of infection. Results are interpreted after 18 - 28 hours incubation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081212 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081212: Mrsaselect - Extended Incubation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081212
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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