510(k) Report

510(k) · Cleared

Recalled · Class II · 2012

Rosen's Stapes Needle Explorer

K822277510(k) TraditionalCleared Aug 25, 198227-day reviewClass I21 CFR 874.4420Recalls 1

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

Kelleher Corp. · KAK Probe, Ent

Cleared on Aug 25, 1982 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled once.

Decided
Aug 25, 1982
Review
27 days
Class
Class I
Product code
KAK
Recalls
1
Predicates
0

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

FIG. 1 — Lineage of K822277Source: 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 KAK? 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)

Recalls of this device

DateClassRecallRoot causeReason
Aug 17, 2012Class IIZ-0407-2013Device DesignThere is a potential for epistaxis during use of the Disposable General Purpose 9 French Temperature Probe.

No ancestor or descendant has a Class I recall.

How does its category compare?

All KAK devices

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

FDA decisions per year · KAK

FDA has decided no KAK device since 2007.

Median 510(k) review, days · KAK

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

Recalls per year · KAK

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

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

Adverse event reports per year · KAK

1in 2023

2017: 12023: 1
2007high 1 (2017) · low 0 (2007)2025

MAUDE reports naming product code KAK, 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—10
20130—00
20140—00
20150—00
20160—00
20170—01
20180—00
20190—00
20200—00
20210—00
20220—00
20230—01
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/K822277 · printed Nov 4, 2026

Cite this page

510(k) Report. “K822277: Rosen's Stapes Needle Explorer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K822277

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