510(k) Report

510(k) · Cleared

Cleared

Tracheal Dilators

K822260510(k) TraditionalCleared Sep 2, 198235-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. · KCG Dilator, Tracheal

Cleared on Sep 2, 1982 after a 35-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Sep 2, 1982
Review
35 days
Class
Class I
Product code
KCG
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K822260Source: 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 KCG? 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 KCG devices

KCG Dilator, Tracheal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KCG

FDA has decided no KCG device since 2007.

Median 510(k) review, days · KCG

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

Recalls per year · KCG

1in 2024

2024: 1
2007high 1 (2024) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KCG

2in 2022

2007: 12008: 22009: 12010: 22011: 22012: 12014: 22016: 12017: 12018: 22019: 12021: 12022: 2
2007high 2 (2008) · low 0 (2013)2025

MAUDE reports naming product code KCG, 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—02
20090—01
20100—02
20110—02
20120—01
20130—00
20140—02
20150—00
20160—01
20170—01
20180—02
20190—01
20200—00
20210—01
20220—02
20230—00
20240—10
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/K822260 · printed Nov 6, 2026

Cite this page

510(k) Report. “K822260: Tracheal Dilators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K822260

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