Cleared Traditional

K250256 - Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000)) (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence.

K250256 · Aventamed Dac · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
90d
Days
Class 2
Risk

K250256 is an FDA 510(k) clearance for the Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tu.... Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Aventamed Dac (Bishopstown, IE). The FDA issued a Cleared decision on April 28, 2025 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Aventamed Dac devices

Submission Details

510(k) Number K250256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2025
Decision Date April 28, 2025
Days to Decision 90 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 89d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Ear, Nose, Throat devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT05741333 Active not recruiting Interventional Industry-sponsored

In-Office Clinical Study of the Solo+ TTD

Pivotal In-Office Clinical Study of the Solo+ Tympanostomy Tube Device

66
Patients (est.)
7
Sites
Treatment
Purpose
Open label
Masking
Condition studied Ear Infection; Otitis Media
Study design Single group
Eligibility All sexes · 6 Months+
Principal investigator Matija Daniel
Sponsor AventaMed DAC (industry)
Started 2023-03-30 → Primary completion 2026-05-01 → Completed 2028-03-01
Primary outcome
Procedure Success
View full study on ClinicalTrials.gov

Regulatory Peers - ETD Tube, Tympanostomy

All 115
Devices cleared under the same product code (ETD) and FDA review panel - the closest regulatory comparables to K250256.
Tula Tympanostomy Tube Delivery Device
K252436 · Tusker Medical, Inc. · Apr 2026
Solo+ Tympanostomy Tube Device (TTD)
K232702 · Aventamed Dac · May 2024
Biowy Tym Tube (TT)
K233658 · Biowy Corporation · Feb 2024
Tympanostomy Tubes
K232059 · Grace Medical, Inc. · Nov 2023
Hummingbird Tympanostomy Tube System
K221254 · Preceptis Medical, Inc. · Jul 2022