510(k) Report

510(k) · Cleared

Cleared

Electroglottograph

K901609510(k) TraditionalCleared Jun 28, 199083-day reviewClass II21 CFR 874.1325

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

Glottal Ent., Inc. · KLX Electroglottograph

Cleared on Jun 28, 1990 after an 83-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jun 28, 1990
Review
83 days
Class
Class II
Product code
KLX
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K901609Source: 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 KLX devices

KLX Electroglottograph: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KLX

FDA has decided no KLX device since 2007.

Median 510(k) review, days · KLX

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

Recalls per year · KLX

No recall names KLX since 2007.

Adverse event reports per year · KLX

1in 2023

2023: 1
2007high 1 (2023) · low 0 (2007)2025

MAUDE reports naming product code KLX, 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—00
20220—00
20230—01
20240—00
20250—00
20260—0—

Recent decisions in KLX

The KLX category page

  • K990240ElectroglottographKay Elemetrics Corp. · 1999
  • K841832Glottal Frequency AnalyserTeltec Electronic Equipment AB · 1984
  • K821079Electroglottograph Naked Egg Boxed EggMs. Kate Teaney · 1982

https://510kreport.com/device/K901609 · printed Nov 3, 2026

Cite this page

510(k) Report. “K901609: Electroglottograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K901609

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