510(k) Report

510(k) · Cleared

Cleared

Knives, Ent

K822205510(k) TraditionalCleared Aug 30, 198238-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. · KTG Knife, Ent

Cleared on Aug 30, 1982 after a 38-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Aug 30, 1982
Review
38 days
Class
Class I
Product code
KTG
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K822205Source: 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 KTG? 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 KTG devices

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

FDA decisions per year · KTG

FDA has decided no KTG device since 2007.

Median 510(k) review, days · KTG

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

Recalls per year · KTG

No recall names KTG since 2007.

Adverse event reports per year · KTG

1in 2020

2008: 12009: 12011: 12012: 22014: 12019: 12020: 1
2007high 2 (2012) · low 0 (2007)2025

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

Recent decisions in KTG

The KTG category page

  • K822280Ent Knife HandlesKelleher Corp. · 1982
  • K822279Lancets for Ear SurgeryKelleher Corp. · 1982
  • K822187Tonsil DissectorsKelleher Corp. · 1982
  • K822203Knife HandleKelleher Corp. · 1982

https://510kreport.com/device/K822205 · printed Nov 6, 2026

Cite this page

510(k) Report. “K822205: Knives, Ent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K822205

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