510(k) · Cleared
ClearedECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mecta Corporation · JXL Block, Bite
Cleared on Jun 4, 2021 as substantially equivalent to K992269 (Somatics, Inc., 1999) after a 385-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Jun 4, 2021
- Review
- 385 days
- Class
- Class II
- Product code
- JXL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992269 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK992269 Ventil-a Oral ProtectorSomatics, Inc. · 1999
- This deviceK201309 ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size MediumMecta Corporation · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992269 | Ventil-a Oral Protector | Somatics, Inc. | 1999 | — |
| 0 (this device) | K201309 | ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium | Mecta Corporation | 2021 | — |
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 JXL? 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 JXL device
- #1 K221469 PATI (Protector Against Tongue Injury)score 5.2 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K992269 | Ventil-a Oral ProtectorSummary page 4…Identification of Predicate Device The identified predicate within this submission is the Somatics, Inc. Ventil-A Oral Protector that was cleared by FDA through 510K No. K992269 (Decision date: October 25, 1999). Description of Device During the passage of the electrical stimulus during ECT, despite the f… | 1999 |
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.
- 3 other devices also cite its predicate K992269.
How does its category compare?
All JXL devicesJXL Block, Bite: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · JXL
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · JXL
Too few JXL 510(k)s in any year since 2007 to give a median.
Recalls per year · JXL
No recall names JXL since 2007.
Adverse event reports per year · JXL
3in 2022
MAUDE reports naming product code JXL, 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 | 1 |
| 2008 | 0 | — | 0 | 12 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 14 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 5 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ECT Cotton Bite Block is a single-use (disposable) oral protector for use during seizures induced by electroconvulsive therapy (ECT), to protect the patient’s lips, teeth and tongue. It is placed between the back molars, with the tongue medial, and one side of the bite block sticking out of the patient's mouth to keep the mouth open.
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/K201309 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201309: ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201309
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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