510(k) · Cleared
ClearedTM Micro-Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xomed, Inc. · ETD Tube, Tympanostomy
Cleared on May 16, 1997 as substantially equivalent to K844061 (Microtek Medical, Inc., 1985) after a 50-day review. Its family tree reaches back 1 generation to 1985.
- Decided
- May 16, 1997
- Review
- 50 days
- Class
- Class II
- Product code
- ETD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K844061 (1985). No later device cites it as a predicate yet.
- Root · 1 generation backK844061 Microtek Irrigation SystemMicrotek Medical, Inc. · 1985
- This deviceK971124 TM Micro-CathetersXomed, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K844061 | Microtek Irrigation System | Microtek Medical, Inc. | 1985 | — |
| 0 (this device) | K971124 | TM Micro-Catheters | Xomed, Inc. | 1997 | — |
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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K844061 | Microtek Irrigation SystemSummary page 2…M Micro-Catheter with Flange and TM Micro-Catheter without Flange described in this notification have the same intended use as Q}e predicate Microtek Irrigation system (K844061) for delivery of fluids into the middle ear . TM Micro-Catheters have the technological characteristics of the predicate tympano… | 1985 |
| Kept off the family tree | K820453 | FDA’s K820453 is The Int-Stopper Our OCR of the scanned summary read K820453, FDA’s number for The Int-Stopper (Burron Medical Products, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “tympanostomy tubes”. Kept off the family tree. Summary page 2…061) for delivery of fluids into the middle ear . TM Micro-Catheters have the technological characteristics of the predicate tympanostomy tubes and butterfly catheters (K820453 or K810461) and so do not raise any new issues of safety or effectiveness. | 1982 |
| Kept off the family tree | K810461 | FDA’s K810461 is Burron Central Vein Catherization Kit Our OCR of the scanned summary read K810461, FDA’s number for Burron Central Vein Catherization Kit (Burron Medical Products, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “butterfly catheters”. Kept off the family tree. Summary page 2…livery of fluids into the middle ear . TM Micro-Catheters have the technological characteristics of the predicate tympanostomy tubes and butterfly catheters (K820453 or K810461) and so do not raise any new issues of safety or effectiveness. | 1981 |
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 no recall.
How does its category compare?
All ETD devicesETD Tube, Tympanostomy: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 TM Micro-Catheter w/ Flange is intended for use as a temporary (less than 29 days) indwelling catheter for delivery of fluids in the treatment of patients with ear disorders. The TM Micro-Catheter w/o Flange is indicated for the immediate (up to 4 hours) delivery of fluids into the middle ear in treating ear disorders.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971124 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971124: TM Micro-Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971124
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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