Cleared Traditional

K822258 - ESOPHAGEAL BOUGIES

K822258 is an FDA 510(k) clearance for ESOPHAGEAL BOUGIES, manufactured by Kelleher Corp.. The device is a Class 1 Ear, Nose, Throat device with product code KCD cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K822258 · Kelleher Corp. · Ear, Nose, Throat device
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Aug 1982
Decision
27d
Days
Class 1
Risk

K822258 is an FDA 510(k) clearance for the ESOPHAGEAL BOUGIES. Classified as Bougie, Esophageal, Ent (product code KCD), Class I - General Controls.

Submitted by Kelleher Corp. (Mchenry, US). The FDA issued a Cleared decision on August 25, 1982 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4420 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kelleher Corp. devices

FDA 510(k) Submission Details - K822258

510(k) Number K822258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1982
Decision Date August 25, 1982
Days to Decision 27 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 90d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

KCD Device Classification - Class 1, General Controls

Product Code KCD Bougie, Esophageal, Ent
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4420
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.