510(k) Report

510(k) · Cleared

Cleared

Columbia Cna Blood Agar

K791546510(k) TraditionalCleared Sep 17, 197938-day reviewClass I21 CFR 866.2660

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

Isle Media and Sterile Products, Inc. · JSR Kit, Identification, Dermatophyte

Cleared on Sep 17, 1979 after a 38-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Sep 17, 1979
Review
38 days
Class
Class I
Product code
JSR
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K791546Source: FDA 510(k) database · 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.

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

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.

How does its category compare?

All JSR devices

JSR Kit, Identification, Dermatophyte: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JSR

FDA has decided no JSR device since 2007.

Median 510(k) review, days · JSR

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

Recalls per year · JSR

No recall names JSR since 2007.

Adverse event reports per year · JSR

No MAUDE report names JSR since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Isle Media and Sterile Products, Inc.

93 FDA decisions under this applicant name. See the company

  • K831671Modified Soybean Casein Digest BrothIsle Media and Sterile Products, Inc. · 1983
  • K821218Campy-S AgarIsle Media and Sterile Products, Inc. · 1982
  • K820863Media for in-Vitro Diagnostic UseIsle Media and Sterile Products, Inc. · 1982
  • K812795Anaerobic Blood AgarIsle Media and Sterile Products, Inc. · 1981
  • K812797Schaedler AgarsIsle Media and Sterile Products, Inc. · 1981

https://510kreport.com/device/K791546 · printed Nov 6, 2026

Cite this page

510(k) Report. “K791546: Columbia Cna Blood Agar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K791546

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