510(k) Report

510(k) · Cleared

Cleared

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))

K250256510(k) TraditionalCleared Apr 28, 202590-day reviewClass II21 CFR 874.3880

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Aventamed Dac · ETD Tube, Tympanostomy

Cleared on Apr 28, 2025 as substantially equivalent to K232702 (Aventamed Dac, 2024) and 1 other predicate after a 90-day review. Its family tree reaches back 6 generations to 1997.

Decided
Apr 28, 2025
Review
90 days
Class
Class II
Product code
ETD
Recalls
None
Predicates
2

Its longest line of descent runs back 6 generations to K973226 (1997). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2024: 1 other ancestorK973226 · Tubingen Tympanic Ventilation Tube, Tympanic Ventilation Tubes with Ene/S, Diabolo Tympanic Ventilation Tube, Minimal T) · Heinz Kurz GmbH Medizintechnik · 1997K071150 · Trocar Ventilation Tube/with Trocar Tip, Trocar Handle, Model 1015 074, 1015 076, 1015 075, 1015 077, W/ Retention Wire · Heinz Kurz GmbH Medizintechnik · 2007K133921 · Preceptis Tympanostomy Tube Inserter · Preceptis Medical · 2014K142282 · Hummingbird (TM) Tympanostomy Tube System (TTS) · Preceptis Medical · 2015K200952 · Hummingbird Tympanostomy Tube System · Preceptis Medical, Inc. · 2020K221254 · Hummingbird Tympanostomy Tube System · Preceptis Medical, Inc. · 20221995200020052010201520202025
Other ancestors, by generation 1 generation back: 1 other ancestor K221254 · Hummingbird Tympanostomy Tube System · Preceptis Medical, Inc. · 2022K200952 · Hummingbird Tympanostomy Tube System · Preceptis Medical, Inc. · 2020K142282 · Hummingbird (TM) Tympanostomy Tube System (TTS) · Preceptis Medical · 2015K133921 · Preceptis Tympanostomy Tube Inserter · Preceptis Medical · 2014K071150 · Trocar Ventilation Tube/with Trocar Tip, Trocar Handle, Model 1015 074, 1015 076, 1015 075, 1015 077, W/ Retention Wire · Heinz Kurz GmbH Medizintechnik · 2007K973226 · Tubingen Tympanic Ventilation Tube, Tympanic Ventilation Tubes with Ene/S, Diabolo Tympanic Ventilation Tube, Minimal T) · Heinz Kurz GmbH Medizintechnik · 1997−50
  1. Root · 6 generations backK973226 Tubingen Tympanic Ventilation Tube, Tympanic Ventilation Tubes with…Heinz Kurz GmbH Medizintechnik · 1997
  2. 5 generations backK071150 Trocar Ventilation Tube/with Trocar Tip, Trocar Handle, Model 1015…Heinz Kurz GmbH Medizintechnik · 2007
  3. 4 generations backK133921 Preceptis Tympanostomy Tube InserterPreceptis Medical · 2014
  4. 3 generations backK142282 Hummingbird (TM) Tympanostomy Tube System (TTS)Preceptis Medical · 2015
  5. 2 generations backK200952 Hummingbird Tympanostomy Tube SystemPreceptis Medical, Inc. · 2020
  6. 1 generation backK221254 Hummingbird Tympanostomy Tube SystemPreceptis Medical, Inc. · 2022
  7. This deviceK250256 Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+…Aventamed Dac · 2025
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K973226Tubingen Tympanic Ventilation Tube, Tympanic Ventilation Tubes with Ene/S…Heinz Kurz GmbH Medizintechnik1997—
−5K071150Trocar Ventilation Tube/with Trocar Tip, Trocar Handle, Model 1015 074, 1015…Heinz Kurz GmbH Medizintechnik2007—
−4K133921Preceptis Tympanostomy Tube InserterPreceptis Medical2014—
−3K142282Hummingbird (TM) Tympanostomy Tube System (TTS)Preceptis Medical2015—
−2K200952Hummingbird Tympanostomy Tube SystemPreceptis Medical, Inc.2020—
−1K221254Hummingbird Tympanostomy Tube SystemPreceptis Medical, Inc.2022—
0 (this device)K250256Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy…Aventamed Dac2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
202410
FIG. 1 — Lineage of K250256, 1997–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in ETD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new ETD device

  1. #1 K252436 Tula Tympanostomy Tube Delivery Devicescore 12.7 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K232702Solo+ Tympanostomy Tube Device (TTD)
Summary page 7
…used in office settings for pediatric patients 6 months and older. Predicate Devices  Primary Predicate: Solo+ Tympanostomy Tube Device (TTD), AventaMed DAC (K232702)  Secondary Predicate: Hummingbird Tympanostomy Tube System (HTTS), Preceptis Medical Inc. (K221254) Device Desc…
Aventamed Dac2024—
*K221254Hummingbird Tympanostomy Tube System
Summary page 7
…: Solo+ Tympanostomy Tube Device (TTD), AventaMed DAC (K232702)  Secondary Predicate: Hummingbird Tympanostomy Tube System (HTTS), Preceptis Medical Inc. (K221254) Device Description The Solo+ Tympanostomy Tube Device (Solo+ TTD) is a single use, sterile, “all-in-one” surgical instrument…
Preceptis Medical, Inc.2022—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 5.1 years on median.
  • None of the 7 ancestors has a recall.

How does its category compare?

All ETD devices

ETD Tube, Tympanostomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.

FDA decisions per year · ETD

1in 2025

2007: 22008: 12011: 12014: 12015: 32017: 12020: 12022: 12023: 12024: 22025: 12026 (partial year): 1
2007high 3 (2015) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ETD

92in 2015

2015: 92 days median
2007high 92 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · ETD

9in 2024

2010: 22012: 12023: 12024: 9
2007high 9 (2024) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · ETD

1in 2025

2007: 12009: 12010: 42011: 12013: 72014: 42015: 42016: 22017: 72018: 22019: 182020: 32021: 82022: 12023: 42024: 22025: 1
2007high 18 (2019) · low 0 (2008)2025

MAUDE reports naming product code ETD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—01
20081—00
20090—01
20100—24
20111—01
20120—10
20130—07
20141—04
201539204
20160—02
20171—07
20180—02
20190—018
20201—03
20210—08
20221—01
20231—14
20242—92
20251—01
20261—0—

What is it indicated for?

The Solo+ Tympanostomy Tube Device is intended to deliver a tympanostomy tube (also referred to as a ventilation tube) through the tympanic membrane of the patient and is indicated to be used in office settings for pediatric patients 6 months and older.

Indications for use as stated in the FDA summary.

More from Aventamed Dac

2 FDA decisions under this applicant name. See the company

  • K232702Solo+ Tympanostomy Tube Device (TTD)Aventamed Dac · 2024

Recent decisions in ETD

The ETD category page

  • K252436Tula Tympanostomy Tube Delivery DeviceTusker Medical, Inc. · 2026
  • K232702Solo+ Tympanostomy Tube Device (TTD)Aventamed Dac · 2024
  • K233658Biowy Tym Tube (TT)Biowy Corporation · 2024
  • K232059Tympanostomy TubesGrace Medical, Inc. · 2023
  • K221254Hummingbird Tympanostomy Tube SystemPreceptis Medical, Inc. · 2022

https://510kreport.com/device/K250256 · printed Nov 6, 2026

Cite this page

510(k) Report. “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)).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250256

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026