510(k) Report

510(k) · Cleared

Cleared

Myringotomy Knife (Various Types)

K822162510(k) TraditionalCleared Aug 16, 198224-day reviewClass I21 CFR 874.4420

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

Kelleher Corp. · JYP Knife, Myringotomy

Cleared on Aug 16, 1982 after a 24-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Aug 16, 1982
Review
24 days
Class
Class I
Product code
JYP
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K822162Source: FDA 510(k) database · How lineage is built

Get the monthly Device Review Tracker

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 JYP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

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 JYP devices

JYP Knife, Myringotomy: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JYP

FDA has decided no JYP device since 2007.

Median 510(k) review, days · JYP

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

Recalls per year · JYP

No recall names JYP since 2007.

Adverse event reports per year · JYP

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2025

MAUDE reports naming product code JYP, 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—01
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 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/K822162 · printed Nov 6, 2026

Cite this page

510(k) Report. “K822162: Myringotomy Knife (Various Types).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K822162

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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