510(k) Report

510(k) · Cleared

Cleared

Lori Hearing Aid Simulator

K964080510(k) TraditionalCleared Jan 8, 199789-day reviewClass II21 CFR 874.3330

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

Lori Medical Laboratories, Inc. · KHL Hearing Aid, Master

Cleared on Jan 8, 1997 after an 89-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Jan 8, 1997
Review
89 days
Class
Class II
Product code
KHL
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 K964080Source: 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 KHL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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  • Recall history across each candidate’s familyin the report
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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 KHL devices

KHL Hearing Aid, Master: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KHL

FDA has decided no KHL device since 2007.

Median 510(k) review, days · KHL

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

Recalls per year · KHL

No recall names KHL since 2007.

Adverse event reports per year · KHL

No MAUDE report names KHL 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 Lori Medical Laboratories, Inc.

8 FDA decisions under this applicant name. See the company

  • K973376Lori/Lori, Lori-S (Lori Stock Aid)Lori Medical Laboratories, Inc. · 1997
  • K972058Loripro, Loripro IILori Medical Laboratories, Inc. · 1997
  • K952711LORI-ALori Medical Laboratories, Inc. · 1995
  • K940639Lori-Cic Hearing AidLori Medical Laboratories, Inc. · 1994
  • K893723Lori-Model L, Canal in-the-Ear InstrumentLori Medical Laboratories, Inc. · 1989

Recent decisions in KHL

The KHL category page

  • K911726Programmable Auditory Comparator, ModificationBausch & Lomb, Inc. · 1991
  • K894019Resound Demo. Behind-the-Ear HRNG., Model Demo BteResound Corp. · 1989
  • K860171Voroba Programmable Auditory ComparatorVoroba Technologies Assoc. · 1986
  • K854126Craigwell Master Hearing Aid MhaCraigwell Electronics, Ltd. · 1986
  • K802812Rionet Hearing AidKindel & Anderson · 1980

https://510kreport.com/device/K964080 · printed Nov 6, 2026

Cite this page

510(k) Report. “K964080: Lori Hearing Aid Simulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964080

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