510(k) Report

510(k) · Cleared

Cleared

Iowa Oral Performance Isntrument

K920091510(k) TraditionalCleared May 20, 1992133-day reviewClass I21 CFR 890.1615

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

Breakthrough, Inc. · IKE Transducer, Miniature Pressure

Cleared on May 20, 1992 after a 133-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
May 20, 1992
Review
133 days
Class
Class I
Product code
IKE
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K920091Source: 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 lists a 510(k) statement for it but has not posted the file, 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 IKE devices

IKE Transducer, Miniature Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IKE

FDA has decided no IKE device since 2007.

Median 510(k) review, days · IKE

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

Recalls per year · IKE

No recall names IKE since 2007.

Adverse event reports per year · IKE

1in 2021

2021: 1
2007high 1 (2021) · low 0 (2007)2025

MAUDE reports naming product code IKE, 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—00
20170—00
20180—00
20190—00
20200—00
20210—01
20220—00
20230—00
20240—00
20250—00
20260—0—

Recent decisions in IKE

The IKE category page

  • K060125Sonic PalpometerPalpometer Systems, Inc. · 2006
  • K954670Pressore MonitorCleveland Medical Devices, Inc. · 1995
  • K915369The EqualizerAdvanced Rehabilitative Technology, Inc. · 1993
  • K915326Portable Limb Load Monitor (Bmllm-100)Bar Med Pty, Ltd. · 1992
  • K915897FPLWrm Computers · 1992

https://510kreport.com/device/K920091 · printed Nov 4, 2026

Cite this page

510(k) Report. “K920091: Iowa Oral Performance Isntrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K920091

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