510(k) · Cleared
ClearedBiowy Tym Tube (TT)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biowy Corporation · ETD Tube, Tympanostomy
Cleared on Feb 16, 2024 as substantially equivalent to K830228 (Micromedics, Inc., 1983) after a 93-day review. Its family tree reaches back 1 generation to 1983.
- Decided
- Feb 16, 2024
- Review
- 93 days
- Class
- Class II
- Product code
- ETD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K830228 (1983). No later device cites it as a predicate yet.
- Root · 1 generation backK830228 Otological Ventilation Tubes-VariousMicromedics, Inc. · 1983 · Recalled
- This deviceK233658 Biowy Tym Tube (TT)Biowy Corporation · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K830228 | Otological Ventilation Tubes-Various | Micromedics, Inc. | 1983 | 1 |
| 0 (this device) | K233658 | Biowy Tym Tube (TT) | Biowy Corporation | 2024 | — |
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 K252436 Tula Tympanostomy Tube Delivery Devicescore 12.7 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K830228 | Otological Ventilation Tubes-VariousSummary page 4…II REGULATION NUMBER: 21 CFR 874.3880 PRODUCT CODE: ETD CLASSIFICATION 21 CFR 874.3880 NUMBER: PREDICATE DEVICE: Otological Ventilation Tubes (K830228) SPONSOR: Biowy Corporation 27031/27002 Vista Terrace Lake Forest, CA 9… | 1983 |
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?
- Its one ancestor has a recall.
- 4 other devices also cite its predicate K830228.
How does its category compare?
All ETD devicesETD Tube, Tympanostomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · ETD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ETD
92in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ETD
9in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ETD
1in 2025
MAUDE reports naming product code ETD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 1 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 2 | 4 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 7 |
| 2014 | 1 | — | 0 | 4 |
| 2015 | 3 | 92 | 0 | 4 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 18 |
| 2020 | 1 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 8 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 1 | — | 1 | 4 |
| 2024 | 2 | — | 9 | 2 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Biowy Tym Tube products are indicated for where chronic Eustachian tube dysfunction does not respond to conventional therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233658 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233658: Biowy Tym Tube (TT).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233658
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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