510(k) Report

510(k) · Cleared

Cleared

Oxide Anaerobic System

K800430510(k) TraditionalCleared Apr 2, 198036-day reviewClass I21 CFR 866.2120

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

Oxoid U.S.A., Inc. · JTM Anaerobic Box Glove

Cleared on Apr 2, 1980 after a 36-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Apr 2, 1980
Review
36 days
Class
Class I
Product code
JTM
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K800430Source: 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 JTM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • 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 JTM devices

JTM Anaerobic Box Glove: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JTM

FDA has decided no JTM device since 2007.

Median 510(k) review, days · JTM

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

Recalls per year · JTM

No recall names JTM since 2007.

Adverse event reports per year · JTM

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2025

MAUDE reports naming product code JTM, 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—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—01
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Oxoid U.S.A., Inc.

93 FDA decisions under this applicant name. See the company

  • K891593Listeria Selective Enrichment MediumOxoid U.S.A., Inc. · 1989
  • K884026Escherichia Coli 0157 Latex Agglutination Test KitOxoid U.S.A., Inc. · 1989
  • K884208Listeria Selective Medium (Oxford Formulation)Oxoid U.S.A., Inc. · 1988
  • K874303Staphylase TestOxoid U.S.A., Inc. · 1987
  • K872956Sorbitol Macconkey Agar NO. 3 CM 813Oxoid U.S.A., Inc. · 1987

https://510kreport.com/device/K800430 · printed Nov 5, 2026

Cite this page

510(k) Report. “K800430: Oxide Anaerobic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K800430

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