510(k) · Cleared

Cleared

Mueller Hinton II Broth (Cation-Adjusted) with Lysed Horse Blood

K963036510(k) TraditionalCleared Oct 7, 199663-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 Microbiology Systems · JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth

Cleared on Oct 7, 1996 as substantially equivalent to K913459 (Ab Biodisk, 1991) after a 63-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it.

Decided: Oct 7, 1996
Review: 63 days
Class: Class II
Product code: JTZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K913459 (1991). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK913459 The E Test, ModificationAb Biodisk · 1991 · Recalled
This deviceK963036 Mueller Hinton II Broth (Cation-Adjusted) with Lysed Horse BloodBecton Dickinson Microbiology Systems · 1996
Descendant · cites it directly · 0 of its ownK262163 BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller…Becton Dickinson and Company · 2026

Most influential descendants

Showing 1 of 1 · See all

K262163BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton BrothBecton Dickinson and Company · 2026 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K913459	The E Test, Modification	Ab Biodisk	1991	6
0 (this device)	K963036	Mueller Hinton II Broth (Cation-Adjusted) with Lysed Horse Blood	Becton Dickinson Microbiology Systems	1996	—
+1	K262163	BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth	Becton Dickinson and Company	2026	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2026	1	0

FIG. 1 — Lineage of K963036, 1991–2026Source: 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 JTZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JTZ device

#1 K262163 BD BBL Mueller Hinton II Broth…score 12.3 · 2 generations · no Class I recall

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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	Applicant	Decided	Recalls
*	K913459	The E Test, Modification Summary page 1 …lture Medium Classification Name: Culture Medium for Antimicrobial Susceptibility Tests PREDICATE DEVICE: AB Biodisk Etest® for Susceptibility Testing of Pneumococci (K913459) DEVICE DESCRIPTION: INTENDED USE: Mueller Hinton 1l Broth (Cation-Adjusted) with Lysed Horse Blood (MHLHB) is intended for use…	Ab Biodisk	1991	6

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K262163	BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth	Becton Dickinson and Company	2026	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?

Its one ancestor has a recall.
Of its descendants, K262163 (Becton Dickinson and Company, 2026) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JTZ devices

JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JTZ

1in 2014

2007high 1 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JTZ

Too few JTZ 510(k)s in any year since 2007 to give a median.

Recalls per year · JTZ

1in 2025

2007high 2 (2009) · low 0 (2007)2026

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

Adverse event reports per year · JTZ

20in 2025

2007high 27 (2022) · low 0 (2007)2025

MAUDE reports naming product code JTZ, 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	0	—	0	0
2008	0	—	1	1
2009	0	—	2	0
2010	0	—	0	0
2011	0	—	1	1
2012	0	—	0	0
2013	0	—	0	0
2014	1	—	0	0
2015	0	—	0	0
2016	0	—	0	0
2017	0	—	1	0
2018	0	—	0	0
2019	0	—	0	0
2020	0	—	0	0
2021	0	—	0	20
2022	0	—	0	27
2023	0	—	0	20
2024	0	—	0	9
2025	0	—	1	20
2026	1	—	0	—

What is it indicated for?

Use of BBL® Mueller Hinton II Broth (Cation-Adjusted) with Lysed Horse Blood is indicated when Streptococcus pneumoniae has been isolated in pure culture in the clinical laboratory, and a determination is desired as to whether the organism is susceptible, intermediate, or resistant to selected antimicrobial agents. In cases such as these, broth dilution antimicrobial susceptibility testing may be performed on BBL® Mueller Hinton II Broth (Cation-Adjusted) with Lysed Horse Blood, using cefaclor, cefotaxime, ceftrixone, cefuroxime, chloramphenicol, erythromycin, imipenem, penicillin, tetracycline, trimethoprim/sulfamethoxazole, and vancomycin.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K963036 · printed Nov 6, 2026

Cite this page

510(k) Report. “K963036: Mueller Hinton II Broth (Cation-Adjusted) with Lysed Horse Blood.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963036

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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