510(k) Report

510(k) · Cleared

Cleared

I Netilmicin Ria Kit

K790514510(k) TraditionalCleared May 3, 197949-day reviewClass I21 CFR 866.2440

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

Diagnostic Products Corp. · JTB Device, Media Dispensing/Stacking

Cleared on May 3, 1979 after a 49-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
May 3, 1979
Review
49 days
Class
Class I
Product code
JTB
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K790514Source: 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.

Planning a device in JTB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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  • Recall history across each candidate’s familyin the report
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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 JTB devices

JTB Device, Media Dispensing/Stacking: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JTB

FDA has decided no JTB device since 2007.

Median 510(k) review, days · JTB

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

Recalls per year · JTB

No recall names JTB since 2007.

Adverse event reports per year · JTB

No MAUDE report names JTB 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 Diagnostic Products Corp.

321 FDA decisions under this applicant name. See the company

  • K063045Immulite 2000, Immulite 2500 VancomycinDiagnostic Products Corp. · 2006
  • K034055Immulite 2500 CK-MB, 2500 Myoglobin, 2500 Stat Troponin IDiagnostic Products Corp. · 20041 recall
  • K033234Immulite 2500 Automated Immunoassay AnalyzerDiagnostic Products Corp. · 20033 recalls
  • K032881Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total TestosteroneDiagnostic Products Corp. · 20032 recalls
  • K023152Immulite 2000 Allergen-Specific IgeDiagnostic Products Corp. · 2002

Recent decisions in JTB

The JTB category page

  • K802561HI Volume Pumping ChamberAcacia, Inc. · 1980

https://510kreport.com/device/K790514 · printed Nov 6, 2026

Cite this page

510(k) Report. “K790514: I Netilmicin Ria Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K790514

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