Cleared Traditional

TYMPANOSTOMY TUBE (K981575) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K981575 · Grace Medical, Inc. · Ear, Nose, Throat device
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Jul 1998
Decision
72d
Days
Class 2
Risk

K981575 is an FDA 510(k) clearance for the TYMPANOSTOMY TUBE. Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Grace Medical, Inc. (Bartlett, US). The FDA issued a Cleared decision on July 15, 1998 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3880 - 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 Grace Medical, Inc. devices

Submission Details

510(k) Number K981575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1998
Decision Date July 15, 1998
Days to Decision 72 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 89d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ETD Tube, Tympanostomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3880
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - ETD Tube, Tympanostomy

All 9
Devices cleared under the same product code (ETD) and FDA review panel - the closest regulatory comparables to K981575.
Tympanostomy Tubes
K232059 · Grace Medical, Inc. · Nov 2023
Hummingbird Tympanostomy Tube System
K221254 · Preceptis Medical, Inc. · Jul 2022
Hummingbird Tympanostomy Tube System
K200952 · Preceptis Medical, Inc. · Jun 2020
VENTILATION TUBES
K960477 · Smith & Nephew, Inc. · Feb 1996
TYMPANOSTOMY TUBES-VARIOUS
K833246 · Abco Dealers, Inc. · Jan 1985