510(k) Report

510(k) · Cleared

Cleared

Incus Nippers

K822170510(k) TraditionalCleared Aug 24, 198232-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. · JYR Nipper, Malleus

Cleared on Aug 24, 1982 after a 32-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Aug 24, 1982
Review
32 days
Class
Class I
Product code
JYR
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K822170Source: 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 JYR? 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
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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 JYR devices

JYR Nipper, Malleus: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JYR

FDA has decided no JYR device since 2007.

Median 510(k) review, days · JYR

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

Recalls per year · JYR

No recall names JYR since 2007.

Adverse event reports per year · JYR

1in 2022

2007: 12017: 12020: 22021: 12022: 1
2007high 2 (2020) · low 0 (2008)2025

MAUDE reports naming product code JYR, 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—01
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—01
20180—00
20190—00
20200—02
20210—01
20220—01
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

Recent decisions in JYR

The JYR category page

  • K791121Alligator Forecpts, Cupped ForcepsXomed, Inc. · 1979

https://510kreport.com/device/K822170 · printed Nov 6, 2026

Cite this page

510(k) Report. “K822170: Incus Nippers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K822170

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