FDA product code JXL: Block, Bite
JXL is the FDA product code for block, bite. It is a Class II device, regulated under 21 CFR 882.5070 and reviewed by the Neurology panel. FDA has cleared 28 510(k) submissions under JXL, 1 in the last five years, from 25 different applicants. The average 510(k) review took 100 days (median 60).
Classification
| Field | Value |
|---|---|
| Device name | Block, Bite |
| Device class | Class II |
| Regulation | 21 CFR 882.5070 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for JXL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 86 |
| 2021 | 1 | 385 |
| 2023 | 1 | 278 |
Compare with all 510(k) review times · Search every JXL clearance
Top JXL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Somatics, Inc. | 2 | 1999-10-25 |
| United States Endoscopy Group, Inc. | 2 | 1996-01-25 |
| Scott All-Sports, Inc. | 2 | 1990-06-28 |
| Neurovice, LLC | 1 | 2023-02-22 |
| Mecta Corporation | 1 | 2021-06-04 |
20 more applicants have JXL clearances. See the full list in Caduvo.
Most recent JXL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K221469 | Neurovice, LLC | PATI (Protector Against Tongue Injury) | 2023-02-22 | 278 |
| K201309 | Mecta Corporation | ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium | 2021-06-04 | 385 |
| K172978 | Surgovations, LLC | SurgeoBite | 2017-12-22 | 86 |
| K150518 | Dupaco, Inc. | Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm | 2015-06-29 | 119 |
| K050188 | Episafe Medical Devices, Ltd. | EPIGUARD | 2005-04-27 | 90 |
Recalls for JXL devices
openFDA lists no recalls for product code JXL.
Frequently asked questions
What is FDA product code JXL?
JXL is the FDA product code for block, bite. It is a Class II device, regulated under 21 CFR 882.5070 and reviewed by the Neurology panel.
What device class is JXL?
Class II, regulation 21 CFR 882.5070. Typical premarket route: 510(k).
How long does a 510(k) take for product code JXL?
Across 28 cleared submissions the average was 100 days from receipt to decision (median 60).
Which companies have the most JXL clearances?
Somatics, Inc. (2); United States Endoscopy Group, Inc. (2); Scott All-Sports, Inc. (2); Neurovice, LLC (1); Mecta Corporation (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JXL
- Run a recall and safety report across every JXL manufacturer
- Watch product code JXL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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