510(k) Report

510(k) · Cleared

Cleared

Mueller Hinton Agar

K132491510(k) TraditionalCleared Jun 30, 2014326-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

Edge Biologicals, Inc. · JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth

Cleared on Jun 30, 2014 as substantially equivalent to K960420 (Becton Dickinson Microbiology Systems, 1996) after a 326-day review. Its family tree reaches back 1 generation to 1996.

Decided
Jun 30, 2014
Review
326 days
Class
Class II
Product code
JTZ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K960420 (1996). No later device cites it as a predicate yet.

K960420 · Mueller Hinton Agar with 5% Sheep Blood · Becton Dickinson Microbiology Systems · 199619952000200520102015
K960420 · Mueller Hinton Agar with 5% Sheep Blood · Becton Dickinson Microbiology Systems · 19960
  1. Root · 1 generation backK960420 Mueller Hinton Agar with 5% Sheep BloodBecton Dickinson Microbiology Systems · 1996
  2. This deviceK132491 Mueller Hinton AgarEdge Biologicals, Inc. · 2014
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K960420Mueller Hinton Agar with 5% Sheep BloodBecton Dickinson Microbiology Systems1996—
0 (this device)K132491Mueller Hinton AgarEdge Biologicals, Inc.2014—
FIG. 1 — Lineage of K132491, 1996–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K262163 BD BBL Mueller Hinton II Broth…score 12.3 · 2 generations · no Class I recall
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K960420Mueller Hinton Agar with 5% Sheep Blood
Summary page 1
…y Tests Product Code - JTZ Predicate Device: Mueller Hinton Agar with 5% Sheep Blood Becton Dickinson (K960420) 510(k) Summary: Mueller Hinton Agar is a standard basal medium intended for in vitro antimicrobial disk diffusion susceptibili…
Becton Dickinson Microbiology Systems1996—

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?

  • Its one ancestor has no recall.

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. 2014, this device’s year, is highlighted.

FDA decisions per year · JTZ

1in 2014

2014: 12026 (partial year): 1
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

2008: 12009: 22011: 12017: 12025: 1
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

2008: 12011: 12021: 202022: 272023: 202024: 92025: 20
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—11
20090—20
20100—00
20110—11
20120—00
20130—00
20141—00
20150—00
20160—00
20170—10
20180—00
20190—00
20200—00
20210—020
20220—027
20230—020
20240—09
20250—120
20261—0—

What is it indicated for?

Mueller Hinton Agar is a standard basal medium intended for in vitro antimicrobial disk diffusion susceptibility testing of isolated colonies of common, rapidly growing bacteria by the Bauer-Kirby method as standardized by the Clinical and Laboratory Standards Institute (OLSI). This product has not been evaluated for gradient diffusion testing.

Indications for use as stated in the FDA summary.

Recent decisions in JTZ

The JTZ category page

  • K262163BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton BrothBecton Dickinson and Company · 2026
  • K963036Mueller Hinton II Broth (Cation-Adjusted) with Lysed Horse BloodBecton Dickinson Microbiology Systems · 1996
  • K960420Mueller Hinton Agar with 5% Sheep BloodBecton Dickinson Microbiology Systems · 1996
  • K960313Mueller Hinton Agar with 2% NaciRemel, L.P. · 1996
  • K945911Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton AgarsBioclinical Systems, Inc. · 1995

https://510kreport.com/device/K132491 · printed Nov 5, 2026

Cite this page

510(k) Report. “K132491: Mueller Hinton Agar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132491

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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