FDA product code LXQ: Cup, Eye
LXQ is the FDA product code for cup, eye. It is a Unclassified device, reviewed by the Ophthalmic panel. FDA has cleared 5 510(k) submissions under LXQ, from 5 different applicants. The average 510(k) review took 100 days (median 82).
Classification
| Field | Value |
|---|---|
| Device name | Cup, Eye |
| Device class | Unclassified |
| Review panel | OP — Ophthalmic |
| Medical specialty | Unknown |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LXQ clearance
Top LXQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dynarex Corporation | 1 | 2015-09-01 |
| Apothecary Products, Inc. | 1 | 2014-07-09 |
| Tollot Pty.Ltd.(Aaxis Pacific) | 1 | 2005-06-16 |
| John Branch | 1 | 1997-11-04 |
| Advantage Diagnostics Corp. | 1 | 1988-05-13 |
Most recent LXQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K151575 | Dynarex Corporation | Dynarex Eye Cups | 2015-09-01 | 82 |
| K140409 | Apothecary Products, Inc. | FLENTS PLASTIC EYE WASH CUP | 2014-07-09 | 141 |
| K051414 | Tollot Pty.Ltd.(Aaxis Pacific) | EYE CUP, STERILE 1 AND NON STERILE | 2005-06-16 | 16 |
| K971134 | John Branch | VISTA EYESHOWER | 1997-11-04 | 221 |
| K881369 | Advantage Diagnostics Corp. | ADVANCE DIAGNOSTICS DISPOSABLE EYECUP | 1988-05-13 | 42 |
Recalls for LXQ devices
openFDA lists no recalls for product code LXQ.
Frequently asked questions
What is FDA product code LXQ?
LXQ is the FDA product code for cup, eye. It is a Unclassified device, reviewed by the Ophthalmic panel.
What device class is LXQ?
Unclassified. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LXQ?
Across 5 cleared submissions the average was 100 days from receipt to decision (median 82).
Which companies have the most LXQ clearances?
Dynarex Corporation (1); Apothecary Products, Inc. (1); Tollot Pty.Ltd.(Aaxis Pacific) (1); John Branch (1); Advantage Diagnostics Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LXQ
- Run a recall and safety report across every LXQ manufacturer
- Watch product code LXQ 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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