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Neozoline Ventilation Tubes

by Adept Medical Ltd

510(k) K061058Ref NZ3461-100

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

7 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K061058↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 20 Oct 2026.

Regulatory status

as of registry sync 20 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number942190197NZ3461-10079 Basic UDI-DI 09421901970895UDI-DIDate18 Nov 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number09421901970895 UDI-DI Date23 Apr 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK061058 Date12 Jul 2006ClearedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 942190197NZ3461-10079 registered 18 Nov 2024 Active
  • FDA 510(k) K061058 decided 12 Jul 2006 Active
  • FDA GUDID UDI-DI 09421901970895 listed 23 Apr 2024 Listed

Recalls

7 recalls · 7 ongoing · FDA

  • 7 recalls, same reason

    • Ongoing Z-0966-2025 FDA Class II initiated 24 Nov 2024
    • Ongoing Z-0969-2025 FDA Class II initiated 24 Nov 2024
    • Ongoing Z-0965-2025 FDA Class II initiated 24 Nov 2024
    • Ongoing Z-0970-2025 FDA Class II initiated 24 Nov 2024
    • Ongoing Z-0967-2025 FDA Class II initiated 24 Nov 2024
    • Ongoing Z-0963-2025 FDA Class II initiated 24 Nov 2024
    • Ongoing Z-0968-2025 FDA Class II initiated 24 Nov 2024

    Lack of 510(k) clearance.

Timeline

10 dated events

  1. Cleared FDA 510(k) K061058
  2. Listed FDA GUDID 09421901970895
  3. Registered EUDAMED 942190197NZ3461-10079
  4. Recall initiated FDA recalls Z-0966-2025
  5. Recall initiated FDA recalls Z-0969-2025
  6. Recall initiated FDA recalls Z-0965-2025
  7. Recall initiated FDA recalls Z-0970-2025
  8. Recall initiated FDA recalls Z-0967-2025
  9. Recall initiated FDA recalls Z-0963-2025
  10. Recall initiated FDA recalls Z-0968-2025

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Trade name
NeoZoline EUDAMED
Rosen Inserter GUDID
Generic name
Tympanostomy tube inserter, single-use
Model / reference
NZ3461-100
FDA applicant
Adept Medical, Ltd.
Primary DI / UDI-DI
09421901970895
Basic UDI-DI
942190197NZ3461-10079
Direct marketing DI
09421901970895
510(k) Number
FDA product code
ETD 510(k)
JYH GUDID
EMDN code
Q030306 ENT surgery curettes, single-use
GMDN term
Tympanostomy tube inserter, single-use
Device class
Class I EUDAMEDGUDID
Class II 510(k)
Regulation
21 CFR Part 874.3880 510(k)
874.4420 GUDID
EU registration type
Standard device
EU market of registration
France
Advisory committee
Ear, Nose, Throat
FDA decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 3 fields differ

FieldEUDAMED510(k)GUDID
FDA product codeEUDAMED
—
510(k)
ETD
GUDID
JYH
Device classEUDAMED
Class I
510(k)
Class II
GUDID
Class I
Regulation numberEUDAMED
—
510(k)
874.3880
GUDID
874.4420

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Neozoline Ventilation Tubes are classified as tympanostomy tubes, designed for the surgical placement in the tympanic membrane to maintain middle ear aeration and drainage of fluid in conditions such as chronic otitis media with effusion. These tubes facilitate ventilation of the middle ear, reducing pressure and preventing recurrent infections by allowing fluid to escape while permitting airflow.

These tubes are supplied sterile and intended for single-use. They are classified under FDA device class II and comply with the MDR (Medical Device Regulation). Available in multiple sizes and reference codes (e.g., 3013557562, 1045254), they are regulated under the product code ETD and are intended for use in otolaryngological procedures. Storage and handling must adhere to sterile medical device protocols to ensure safety and efficacy.

Devices cleared under K061058

48 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K061058
UDI-DISize and differences
NeoZoline NZ3111
ADEPT MEDICAL LIMITED
NZ3111 / NZ311109421901970000 —On the market
NeoZoline NZ3111-2
ADEPT MEDICAL LIMITED
NZ3111-2 / NZ3111-209421901970017 —On the market
NeoZoline NZ3112
ADEPT MEDICAL LIMITED
NZ3112 / NZ311209421901970024 —On the market
NeoZoline NZ3112-2
ADEPT MEDICAL LIMITED
NZ3112-2 / NZ3112-209421901970031 —On the market
NeoZoline NZ3121
ADEPT MEDICAL LIMITED
NZ3121 / NZ312109421901970048 —On the market
NeoZoline NZ3121-2
ADEPT MEDICAL LIMITED
NZ3121-2 / NZ3121-209421901970963 —On the market
NeoZoline NZ3122
ADEPT MEDICAL LIMITED
NZ3122 / NZ312209421901970062 —On the market
NeoZoline NZ3122-2
ADEPT MEDICAL LIMITED
NZ3122-2 / NZ3122-209421901970079 —On the market
NeoZoline NZ3123
ADEPT MEDICAL LIMITED
NZ3123 / NZ312309421901970086 —On the market
NeoZoline NZ3123-2
ADEPT MEDICAL LIMITED
NZ3123-2 / NZ3123-209421901970093 —On the market
NeoZoline NZ3124
ADEPT MEDICAL LIMITED
NZ3124 / NZ312409421901970109 —On the market
NeoZoline NZ3124-2
ADEPT MEDICAL LIMITED
NZ3124-2 / NZ3124-209421901970116 —On the market
NeoZoline NZ3141
ADEPT MEDICAL LIMITED
NZ3141 / NZ314109421901970123 —On the market
NeoZoline NZ3141-2
ADEPT MEDICAL LIMITED
NZ3141-2 / NZ3141-209421901970130 —On the market
NeoZoline NZ3141BLUE
ADEPT MEDICAL LIMITED
NZ3141BLUE / NZ3141BLUE09421901970918 —On the market
NeoZoline NZ3151
ADEPT MEDICAL LIMITED
NZ3151 / NZ315109421901970147 —On the market
NeoZoline NZ3151-2
ADEPT MEDICAL LIMITED
NZ3151-2 / NZ3151-209421901970154 —On the market
NeoZoline NZ3211-2
ADEPT MEDICAL LIMITED
NZ3211-2 / NZ3211-209421901970178 —On the market
NeoZoline NZ3211Blue
ADEPT MEDICAL LIMITED
NZ3211Blue / NZ3211Blue09421901970826 —On the market
NeoZoline NZ3211Blue-2
ADEPT MEDICAL LIMITED
NZ3211Blue-2 / NZ3211Blue-209421901970833 —On the market
NeoZoline NZ3212
ADEPT MEDICAL LIMITED
NZ3212 / NZ321209421901970185 —On the market
NeoZoline NZ3212-2
ADEPT MEDICAL LIMITED
NZ3212-2 / NZ3212-209421901970192 —On the market
NeoZoline NZ3213
ADEPT MEDICAL LIMITED
NZ3213 / NZ321309421901970208 —On the market
NeoZoline NZ3213-2
ADEPT MEDICAL LIMITED
NZ3213-2 / NZ3213-209421901970215 —On the market
NeoZoline NZ3213Blue
ADEPT MEDICAL LIMITED
NZ3213Blue / NZ3213Blue09421901970840 —On the market
NeoZoline NZ3213Blue-2
ADEPT MEDICAL LIMITED
NZ3213Blue-2 / NZ3213Blue-209421901970857 —On the market
NeoZoline NZ3214
ADEPT MEDICAL LIMITED
NZ3214 / NZ321409421901970222 —On the market
NeoZoline NZ3214-2
ADEPT MEDICAL LIMITED
NZ3214-2 / NZ3214-209421901970239 —On the market
NeoZoline NZ3220
ADEPT MEDICAL LIMITED
NZ3220 / NZ322009421901970246 —On the market
NeoZoline NZ3220-2
ADEPT MEDICAL LIMITED
NZ3220-2 / NZ3220-209421901970253 —On the market
NeoZoline NZ3223
ADEPT MEDICAL LIMITED
NZ3223 / NZ322309421901970260 —On the market
NeoZoline NZ3223-2
ADEPT MEDICAL LIMITED
NZ3223-2 / NZ3223-209421901970277 —On the market
NeoZoline NZ3223Blue
ADEPT MEDICAL LIMITED
NZ3223Blue / NZ3223Blue09421901970864 —On the market
NeoZoline NZ3223Blue-2
ADEPT MEDICAL LIMITED
NZ3223Blue-2 / NZ3223Blue-209421901970871 —On the market
NeoZoline NZ3224
ADEPT MEDICAL LIMITED
NZ3224 / NZ322409421901970284 —On the market
NeoZoline NZ3224-2
ADEPT MEDICAL LIMITED
NZ3224-2 / NZ3224-209421901970291 —On the market
NeoZoline NZ3226
ADEPT MEDICAL LIMITED
NZ3226 / NZ322609421901970307 —On the market
NeoZoline NZ3226-2
ADEPT MEDICAL LIMITED
NZ3226-2 / NZ3226-209421901970314 —On the market
NeoZoline NZ3227
ADEPT MEDICAL LIMITED
NZ3227 / NZ322709421901970321 —On the market
NeoZoline NZ3227-2
ADEPT MEDICAL LIMITED
NZ3227-2 / NZ3227-209421901970338 —On the market
NeoZoline NZ3306
ADEPT MEDICAL LIMITED
NZ3306 / NZ330609421901970345 —No longer on the market
NeoZoline NZ3306-2
ADEPT MEDICAL LIMITED
NZ3306-2 / NZ3306-209421901970352 —No longer on the market
NeoZoline NZ3309
ADEPT MEDICAL LIMITED
NZ3309 / NZ330909421901970369 —No longer on the market
NeoZoline NZ3309-2
ADEPT MEDICAL LIMITED
NZ3309-2 / NZ3309-209421901970376 —No longer on the market
NeoZoline NZ3312
ADEPT MEDICAL LIMITED
NZ3312 / NZ331209421901970383 —No longer on the market
NeoZoline NZ3312-2
ADEPT MEDICAL LIMITED
NZ3312-2 / NZ3312-209421901970390 —No longer on the market
NeoZoline NZ3321
ADEPT MEDICAL LIMITED
NZ3321 / NZ332109421901970406 —No longer on the market
NeoZoline NZ3321-2
ADEPT MEDICAL LIMITED
NZ3321-2 / NZ3321-209421901970413 —No longer on the market

Similar devices in this category

Other devices filed under ENT SURGERY INSTRUMENTS, SINGLE-USE.

Other devices from Adept Medical Ltd

See all devices from Adept Medical Ltd →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)