510(k) · Cleared
ClearedBblchromagar Mrsa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson & CO · JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Cleared on Nov 22, 2004 as substantially equivalent to K863821 (Gibco Laboratories Life Technologies, Inc., 1986) after a 41-day review. Its family tree reaches back 1 generation to 1986. 12 later devices descend from it.
- Decided
- Nov 22, 2004
- Review
- 41 days
- Class
- Class II
- Product code
- JSO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K863821 (1986). 12 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK863821 Mueller Hinton Agar W/4%Nacl and OxacillinGibco Laboratories Life Technologies, Inc. · 1986 · Recalled
- This deviceK042812 Bblchromagar MrsaBecton, Dickinson & CO · 2004
- Descendant · cites it directly · 4 of its ownK070361 MrsaselectBio-Rad · 2007
- Descendant · cites it directly · 3 of its ownK082140 Xpert Mrsa/SA Blood Culture AssayCepheid · 2008 · Recalled
- Descendant · 2 generations on · 3 of its ownK081212 Mrsaselect - Extended IncubationBio-Rad · 2008 · Recalled
- Descendant · 3 generations on · 2 of its ownK100589 Mrsa Select - Skin and Soft Tissue Wound SpecimensBio-Rad · 2010
- Descendant · 2 generations on · 2 of its ownK101879 Xpert Mrsa/SA BC (Blood Culture) Assay Model Gxmrsa/SA-BC-10Cepheid · 2010 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K070361MrsaselectBio-Rad · 2007 · cites it directly4descendants
- K082140Xpert Mrsa/SA Blood Culture AssayCepheid · 2008 · cites it directly3descendants
- K081212Mrsaselect - Extended IncubationBio-Rad · 2008 · 2 generations on3descendants
- K100589Mrsa Select - Skin and Soft Tissue Wound SpecimensBio-Rad · 2010 · 3 generations on2descendants
- K101879Xpert Mrsa/SA BC (Blood Culture) Assay Model Gxmrsa/SA-BC-10Cepheid · 2010 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K863821 | Mueller Hinton Agar W/4%Nacl and Oxacillin | Gibco Laboratories Life Technologies, Inc. | 1986 | 1 |
| 0 (this device) | K042812 | Bblchromagar Mrsa | Becton, Dickinson & CO | 2004 | — |
| +1 | K070361 | Mrsaselect | Bio-Rad | 2007 | — |
| +1 | K082140 | Xpert Mrsa/SA Blood Culture Assay | Cepheid | 2008 | 2 |
| +2 | K081212 | Mrsaselect - Extended Incubation | Bio-Rad | 2008 | 1 |
| +3 | K100589 | Mrsa Select - Skin and Soft Tissue Wound Specimens | Bio-Rad | 2010 | — |
| +2 | K101879 | Xpert Mrsa/SA BC (Blood Culture) Assay Model Gxmrsa/SA-BC-10 | Cepheid | 2010 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2010 | 3 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K863821 | Mueller Hinton Agar W/4%Nacl and OxacillinSummary page 1…edium DEVICE CLASSIFICATION: 21 CFR§866.1700, Class II PREDICATE DEVICES: BBL T M Oxacillin Screen Agar (K863821) INTENDED USE: BBLTM CHROMagarTM MRSA is a selective and differential medium for the qualitative direct detection of nasal col… | 1986 |
What descends from it? (12)
See all 124 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?
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.
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?
BBLTI CHROMagar TM MRSA is a selective and differential medium for the qualitative direct detection of nasal colonization by methicillin resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA infections in healthcare settings. The test is performed on anterior nares swab specimens from patients and healthcare workers to screen for MRSA colonization. BBLTM CHROMagar TM MRSA is not intended to diagnose MRSA infection nor to guide or monitor treatment for infections.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042812 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042812: Bblchromagar Mrsa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042812
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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