Cleared Traditional

K822164 - EAR SPECULI

K822164 is the FDA 510(k) clearance for EAR SPECULI by Kelleher Corp.. It is a Class 1 General & Plastic Surgery device (product code EPY) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K822164 · Kelleher Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1982
Decision
19d
Days
Class 1
Risk

K822164 is an FDA 510(k) clearance for the EAR SPECULI. Classified as Speculum, Ent (product code EPY), Class I - General Controls.

Submitted by Kelleher Corp. (Walker, US). The FDA issued a Cleared decision on August 11, 1982 after a review of 19 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.1800 - the FDA general and plastic surgery 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

Submission Details

510(k) Number K822164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1982
Decision Date August 11, 1982
Days to Decision 19 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 115d · This submission: 19d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EPY Speculum, Ent
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.1800
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.

Regulatory Peers - EPY Speculum, Ent

All 9
Devices cleared under the same product code (EPY) and FDA review panel - the closest regulatory comparables to K822164.
JAKOBI SURG. INSTRUMENTS #7 44/47
K834189 · Imm Enterprises , Ltd. · Mar 1984
UNIVERSAL SPECULUM HOLDER
K822370 · Treace Medical, Inc. · Sep 1982
EAR SURGERY SPECULUM
K822373 · Treace Medical, Inc. · Sep 1982
EAR AND NOSE SPECULA
K791123 · Xomed, Inc. · Jul 1979
OTOSCOPE SPECULA
K780723 · Abco Dealers, Inc. · May 1978
BARRAQUER OVAL SPECULUM-VARIOUS SIZES
K772370 · Edward Weck, Inc. · Jan 1978