510(k) · Cleared

Cleared

BBL Chromagar Mrsa II

K092767510(k) TraditionalCleared Aug 20, 2010345-day reviewClass II21 CFR 866.1700

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Becton, Dickinson & CO · JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

Cleared on Aug 20, 2010 as substantially equivalent to K042812 (Becton, Dickinson & CO, 2004) and 1 other predicate after a 345-day review. Its family tree reaches back 2 generations to 1986.

Decided: Aug 20, 2010
Review: 345 days
Class: Class II
Product code: JSO
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K863821 (1986). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK863821 Mueller Hinton Agar W/4%Nacl and OxacillinGibco Laboratories Life Technologies, Inc. · 1986 · Recalled
1 generation backK042812 Bblchromagar MrsaBecton, Dickinson & CO · 2004
This deviceK092767 BBL Chromagar Mrsa IIBecton, Dickinson & CO · 2010

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K863821	Mueller Hinton Agar W/4%Nacl and Oxacillin	Gibco Laboratories Life Technologies, Inc.	1986	1
−1	K042812	Bblchromagar Mrsa	Becton, Dickinson & CO	2004	—
0 (this device)	K092767	BBL Chromagar Mrsa II	Becton, Dickinson & CO	2010	—

FIG. 1 — Lineage of K092767, 1986–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (2)

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	Applicant	Decided	Recalls
*	K042812	Bblchromagar Mrsa Summary page 1 …Culture Medium DEVICE CLASSIFICATION: 21 CFR§866.1700, Class II PREDICATE DEVICES: BBLTM CHROMagar T M'MRSA (K0428 12) BBLTM Oxacillin Screen Agar (K863821) INTENDED USE: HBLTM CHROMagar'rm MRSA II is…	Becton, Dickinson & CO	2004	—
*	K863821	Mueller Hinton Agar W/4%Nacl and Oxacillin Summary page 1 ….1700, Class II PREDICATE DEVICES: BBLTM CHROMagar T M'MRSA (K0428 12) BBLTM Oxacillin Screen Agar (K863821) INTENDED USE: HBLTM CHROMagar'rm MRSA II is a selective and differential chromogenic m~edium for the qualitative direct detec…	Gibco Laboratories Life Technologies, Inc.	1986	1

Also cleared against K042812: 3 other devices →

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 24 years and passes through 2 companies; a new generation was cleared every 18.1 years on median.
1 of the 2 ancestors has a recall of any class.
3 other devices also cite its predicate K042812.

How does its category compare?

All JSO devices

JSO 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

2007high 5 (2010) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JSO

262in 2016

2007high 326 (2010) · low 262 (2016)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JSO

15in 2022

2007high 15 (2022) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JSO

513in 2025

2007high 513 (2025) · low 0 (2007)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?

BBL CHROMagar MRSA II is a selective and differential chromogenic 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 to screen for MRSA colonization.

BBL CHROMagar MRSA II is not intended to diagnose, guide or monitor treatment for MRSA infections. A negative result does not preclude MRSA nasal colonization. Concomitant cultures are necessary for organism identification, susceptibility testing or epidemiological typing.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K092767 · printed Nov 6, 2026

Cite this page

510(k) Report. “K092767: BBL Chromagar Mrsa II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092767

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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