Cleared Traditional

K822369 - MICRO & MINI-MICRO ALLIGATOR FORCEPS

K822369 is an FDA 510(k) clearance for MICRO & MINI-MICRO ALLIGATOR FORCEPS, manufactured by Treace Medical, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code KAE cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K822369 · Treace Medical, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1982
Decision
34d
Days
Class 1
Risk

K822369 is an FDA 510(k) clearance for the MICRO & MINI-MICRO ALLIGATOR FORCEPS. Classified as Forceps, Ent (product code KAE), Class I - General Controls.

Submitted by Treace Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 9, 1982 after a review of 34 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 Treace Medical, Inc. devices

FDA 510(k) Submission Details - K822369

510(k) Number K822369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1982
Decision Date September 09, 1982
Days to Decision 34 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
56d faster than avg
Panel avg: 90d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

KAE Device Classification - Class 1, General Controls

Product Code KAE Forceps, 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.

Regulatory Peers - KAE Forceps, Ent

All 13
Devices cleared under the same product code (KAE) and FDA review panel - the closest regulatory comparables to K822369.
GOLD ALLIGATOR FORCEPS
K833608 · Microtek Medical, Inc. · Jan 1984
CUPPED FORCEPS
K833605 · Microtek Medical, Inc. · Jan 1984
MCGEE FORCEPS
K833607 · Microtek Medical, Inc. · Jan 1984
OFFICE ECONO-FORCEPS
K822372 · Treace Medical, Inc. · Sep 1982
YARMO NASAL CARTILAGE SOFTENER
K812895 · American V. Mueller · Nov 1981
HILDYARD POST NASAL FORCEP
K772377 · Edward Weck, Inc. · Jan 1978