510(k) Report

510(k) · Cleared

Cleared

Mueller Hinton Agar with 5% Sheep Blood

K960420510(k) TraditionalCleared Apr 4, 199666-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 Apr 4, 1996 after a 66-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Apr 4, 1996
Review
66 days
Class
Class II
Product code
JTZ
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2014: 1 descendant cleared1995200020052010201520202025
  1. This deviceK960420 Mueller Hinton Agar with 5% Sheep BloodBecton Dickinson Microbiology Systems · 1996
  2. Descendant · cites it directly · 0 of its ownK132491 Mueller Hinton AgarEdge Biologicals, Inc. · 2014

Most influential descendants

Showing 1 of 1 · See all
  • K132491Mueller Hinton AgarEdge Biologicals, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K960420Mueller Hinton Agar with 5% Sheep BloodBecton Dickinson Microbiology Systems1996—
+1K132491Mueller Hinton AgarEdge Biologicals, Inc.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
FIG. 1 — Lineage of K960420, 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), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K132491Mueller Hinton AgarEdge Biologicals, Inc.20140

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?

  • Of its descendants, K132491 (Edge Biologicals, Inc., 2014) 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

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—

More from Becton Dickinson Microbiology Systems

33 FDA decisions under this applicant name. See the company

  • K993577Cefotaxime/Clavulanic, 30/10UG, BBL Sensi-Disc and Ceftazidime/Clavulanic Acid, 30/10UG, BBL Sensi-DiscBecton Dickinson Microbiology Systems · 1999
  • K984631Bdprobetec ET Chlamydia Trachomatis and Neisseria Gonorrhoeae Amplified Dna AssayBecton Dickinson Microbiology Systems · 19992 recalls
  • K981517Cefdinir, 5 UG, Sensi-DiscBecton Dickinson Microbiology Systems · 1998
  • K980683Trovafloxacin 10G, Sensi-DiscBecton Dickinson Microbiology Systems · 1998
  • K974578Grepafloxacin, 5 MG, Sensi-DiscBecton Dickinson Microbiology Systems · 1998

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
  • K132491Mueller Hinton AgarEdge Biologicals, Inc. · 2014
  • K963036Mueller Hinton II Broth (Cation-Adjusted) with Lysed Horse 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/K960420 · printed Nov 6, 2026

Cite this page

510(k) Report. “K960420: Mueller Hinton Agar with 5% Sheep Blood.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960420

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026