510(k) Report

510(k) · Cleared

Cleared

Omni-Matrix

K930151510(k) TraditionalCleared Sep 23, 1993254-day reviewClass I21 CFR 872.4565

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

Innovative Technology, Ltd. · JEP Retainer, Matrix

Cleared on Sep 23, 1993 after a 254-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Sep 23, 1993
Review
254 days
Class
Class I
Product code
JEP
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K930151Source: FDA 510(k) database · How lineage is built

Get the monthly Device Review Tracker

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 JEP? 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
Get a 510(k) Report

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 JEP devices

JEP Retainer, Matrix: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JEP

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JEP

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

Recalls per year · JEP

No recall names JEP since 2007.

Adverse event reports per year · JEP

8in 2023

2014: 12016: 22023: 8
2007high 8 (2023) · low 0 (2007)2025

MAUDE reports naming product code JEP, 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
20091—00
20100—00
20110—00
20120—00
20130—00
20140—01
20150—00
20160—02
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—08
20240—00
20250—00
20260—0—

More from Innovative Technology, Ltd.

2 FDA decisions under this applicant name. See the company

  • K924008Sterile Film Wound DressingInnovative Technology, Ltd. · 1992

Recent decisions in JEP

The JEP category page

  • K091533Slicks Sectional Matrix and Matrix Bands, Models SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175…Garrison Dental Solutions · 2009
  • K831136Double Bow Tooth SeparatorAlmore Intl., Inc. · 1983

https://510kreport.com/device/K930151 · printed Nov 4, 2026

Cite this page

510(k) Report. “K930151: Omni-Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K930151

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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