510(k) Report

510(k) · Cleared

Cleared

Oral Sponge

K830675510(k) TraditionalCleared Mar 24, 198321-day reviewClass I21 CFR 878.4800

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

Unisplint Corp. · GEO File, Surgical, General & Plastic Surgery

Cleared on Mar 24, 1983 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Mar 24, 1983
Review
21 days
Class
Class I
Product code
GEO
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K830675Source: 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 GEO devices

GEO File, Surgical, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEO

FDA has decided no GEO device since 2007.

Median 510(k) review, days · GEO

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

Recalls per year · GEO

No recall names GEO since 2007.

Adverse event reports per year · GEO

No MAUDE report names GEO 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 Unisplint Corp.

2 FDA decisions under this applicant name. See the company

  • K820944Dental Arch BarUnisplint Corp. · 1982

Recent decisions in GEO

The GEO category page

  • K844145General Surgical FilesMed-Tool, Inc. · 1984

https://510kreport.com/device/K830675 · printed Nov 6, 2026

Cite this page

510(k) Report. “K830675: Oral Sponge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K830675

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