Cleared Traditional

K822372 - OFFICE ECONO-FORCEPS

K822372 is an FDA 510(k) clearance for OFFICE ECONO-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.

K822372 · Treace Medical, Inc. · Ear, Nose, Throat device
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Sep 1982
Decision
34d
Days
Class 1
Risk

K822372 is an FDA 510(k) clearance for the OFFICE ECONO-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 - K822372

510(k) Number K822372 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 K822372.
CUPPED FORCEPS
K833605 · Microtek Medical, Inc. · Jan 1984
MCGEE FORCEPS
K833607 · Microtek Medical, Inc. · Jan 1984
MICRO & MINI-MICRO ALLIGATOR FORCEPS
K822369 · 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
ALLIGATOR CUP FORCEPS
K772396 · Edward Weck, Inc. · Jan 1978