510(k) Report

510(k) · Cleared

Cleared

Shea's Ear Speculum Holder Port Manns

K822011510(k) TraditionalCleared Aug 12, 198235-day reviewClass I21 CFR 878.1800

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

Kelleher Corp. · JYK Holder, Ear Speculum

Cleared on Aug 12, 1982 after a 35-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Aug 12, 1982
Review
35 days
Class
Class I
Product code
JYK
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K822011Source: 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 JYK devices

JYK Holder, Ear Speculum: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JYK

FDA has decided no JYK device since 2007.

Median 510(k) review, days · JYK

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

Recalls per year · JYK

No recall names JYK since 2007.

Adverse event reports per year · JYK

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2025

MAUDE reports naming product code JYK, 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—01
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 Kelleher Corp.

94 FDA decisions under this applicant name. See the company

  • K822618Emergency Tracheostomy Instrument SetKelleher Corp. · 1983
  • K822268Nagashima NS-Iii ElectronystagmographKelleher Corp. · 1983
  • K823083Electrosurgical UnitKelleher Corp. · 1982
  • K823111Nystymograph AccessKelleher Corp. · 1982
  • K822252Ent Treatment UnitsKelleher Corp. · 1982

https://510kreport.com/device/K822011 · printed Nov 6, 2026

Cite this page

510(k) Report. “K822011: Shea's Ear Speculum Holder Port Manns.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K822011

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