510(k) · Cleared
ClearedEndolymphatic Sac to Mastoid T-Shunt
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exmoor Plastics, Ltd. · ESZ Tube, Shunt, Endolymphatic
Cleared on Jan 27, 1998 after a 78-day review. The FDA summary names its predicate without a number.
- Decided
- Jan 27, 1998
- Review
- 78 days
- Class
- Class II
- Product code
- ESZ
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 ESZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Richards Endolymphatic Shunt Tube (Austin Modification) Named without a submission number | |
| * | — | Richards Silicone Elastomer Endolymphatic Shunt Tube (House type) Named without a submission number |
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.
How does its category compare?
All ESZ devicesESZ Tube, Shunt, Endolymphatic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ESZ
FDA has decided no ESZ device since 2007.
Median 510(k) review, days · ESZ
Too few ESZ 510(k)s in any year since 2007 to give a median.
Recalls per year · ESZ
No recall names ESZ since 2007.
Adverse event reports per year · ESZ
1in 2020
MAUDE reports naming product code ESZ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Endolymphatic Sac fluid increases during Meniere's disease attacks. This simple 'T" type endolymphatic sac shunt is designed to act as a continuous drain, allowing endolymphatic sac fluid to be shunted into the Mastoid. The shunt is placed in the sac along with decompression of the sac and the adjacent dura.
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/K974224 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974224: Endolymphatic Sac to Mastoid T-Shunt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974224
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026