Inventis Middle Ear Analyzer, Flute Basic, Inventis Middle Ear Analyzer, Flute …
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K133013 FDA 510(k)
- FDA Product Code
- ETY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.1090 FDA 510(k)
- Regulation Number
- 874.1090 FDA 510(k)
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Inventis Middle Ear Analyzer Flute is a diagnostic device classified as an Auditory Impedance Tester (ETY), designed to assess middle ear function. It performs tympanometry, reflex threshold testing, manual reflex and reflex decay tests, and optional high-frequency tympanometry (226 Hz probe tone with an optional license). The device evaluates middle ear pressure, mobility, and acoustic reflexes to aid in diagnosing conditions such as otitis media, Eustachian tube dysfunction, or hearing impairments.
The Flute series is supplied as a reusable clinical instrument, featuring an aluminium probe for durability and ease of maintenance. It operates within a pressure range of -600 to +400 daPa and is intended for use in Ear, Nose, and Throat (ENT) settings. Authorized under FDA 510(k) clearance and MDR compliance, the device adheres to regulatory standards for Class II medical devices (874.1090). Sterilization and storage instructions are manufacturer-specific and must be followed as per Inventis S.r.l. guidelines.
Frequently asked questions
What types of tests can the Inventis Middle Ear Analyzer Flute perform, and how do they help in diagnosing ear conditions?
The Inventis Middle Ear Analyzer Flute performs tympanometry, reflex threshold testing, manual reflex tests, and reflex decay tests. These tests measure middle ear pressure, mobility, and acoustic reflexes to help diagnose conditions like otitis media, Eustachian tube dysfunction, or hearing impairments. The optional high-frequency tympanometry (226 Hz probe tone) further refines assessments when paired with the appropriate license.
Is the Inventis Middle Ear Analyzer Flute reusable, and what materials are used in its construction?
Yes, the Inventis Middle Ear Analyzer Flute is designed as a reusable clinical instrument. It features an aluminum probe, which is durable and designed for easy maintenance, ensuring longevity and hygiene in ENT settings.
What pressure range does the device operate within, and what kind of clinical environment is it intended for?
The device operates within a pressure range of -600 to +400 daPa, making it suitable for assessing a wide range of middle ear conditions. It is specifically intended for use in Ear, Nose, and Throat (ENT) clinical settings.
How should the Inventis Middle Ear Analyzer Flute be sterilized and stored, according to the manufacturer?
Sterilization and storage instructions are manufacturer-specific and must be followed as per Inventis S.r.l. guidelines. Since it is a reusable device, proper cleaning and sterilization protocols are critical to maintain its performance and ensure patient safety.
What regulatory pathways has the Inventis Middle Ear Analyzer Flute followed, and what classification does it hold?
The device has undergone FDA 510(k) clearance and complies with the EU Medical Device Regulation (MDR). It is classified as a Class II medical device under the product code ETY (Auditory Impedance Tester) and adheres to regulatory standards outlined in 874.1090.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Flute, diagnostic middle ear analyzer ‹ INVENTIS, Inventis Flute Plus Middle Ear Analyzer - oaktreeproducts.com, Middle-ear analyzers, screening, diagnostic, clinical ‹ INVENTIS
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K133013 | Class II | Active |
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Manufacturer
- Manufacturer
- INVENTIS S.r.l.
Sources (2)
- FDA 510(k) K133013 24 fields · synced Sep 20, 2026
- EUDAMED 1 fields · synced Jun 19, 2026