Skip to content

Rigid Suction Tips

by Kelleher Corp. 510(k)

Active United States

510(k) K822255

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK822255 Date25 Aug 1982ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KTR
Device Class
Class II
Regulation
21 CFR Part 874.4680
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Rigid Suction Tips are classified as a rigid bronchoscope aspirating tube. This device is designed to facilitate suctioning procedures within the ear, nose, and throat medical specialty.

This device is a Class II medical device regulated under 21 CFR 874.4680. It has received FDA 510(k) clearance under the identifier K822255.

Other devices from Kelleher Corp.

See all devices from Kelleher Corp. →

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary clinical use for the Rigid Suction Tips?

    These devices are designed to function as rigid bronchoscope aspirating tubes. They are specifically intended to facilitate suctioning procedures during medical interventions within the ear, nose, and throat specialty.

  • How is this device regulated?

    The Rigid Suction Tips are classified as a Class II medical device under 21 CFR 874.4680. The device has received FDA 510(k) clearance under the identifier K822255, confirming it is substantially equivalent to predicate devices.

  • Who is the manufacturer of these suction tips?

    The Rigid Suction Tips are manufactured by Kelleher Corp., located in McHenry, Illinois. The company manages the production and regulatory filings for this specific aspirating tube.